Keyword "RHPI:REGULATORY" - List of latest news (567 results)

01:33 US to phase out many synthetic food dyes, Kennedy and FDA head say

Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary said on Tuesday that the agency plans to remove petroleum-based synthetic food dyes from the U.S. food supply by revoking authorizations of some and working with industry to voluntarily remove others.

21/04 Gilead says Trodelvy-Keytruda combo effective for aggressive breast cancer type

Gilead Sciences said on Monday a late-stage study showed that its drug Trodelvy used in combination with Merck's immunotherapy Keytruda significantly slowed disease progression in patients with an aggressive type of breast cancer.

18/04 Exclusive: FDA fires most negotiators for pharma user fee talks, sources say

The U.S. Food and Drug Administration's mass layoffs included senior negotiators in talks with the pharmaceutical industry over renewing the user fee programs that fund the regulator's drug review system, six sources familiar with the matter said.

17/04 UK approves combination therapies of GSK's blood cancer drug Blenrep

GSK said on Thursday two combination therapies with its cancer drug, Blenrep, have received approval from British authorities for the treatment of a type of blood cancer in adults who had received at least one other therapy previously.

17/04 Lilly weight-loss pill works as well as Ozempic, shares surge

Eli Lilly's experimental pill worked as well as blockbuster drug Ozempic to lower weight and blood sugar in a trial of diabetes patients, and the company said it expects to seek regulatory approvals by the end of the year.

17/04 US CDC advisers recommend lowering the age for RSV shots to 50-59 years

The U.S. Centers for Disease Control and Prevention's panel of outside experts on Wednesday recommended the use of respiratory syncytial virus vaccines in younger adults who are at increased risk of severe illness from the virus.

16/04 Kennedy plans studies to look for environmental contributors to autism

U.S. Health Secretary Robert F. Kennedy Jr. announced on Wednesday that he is planning new studies to identify environmental contributors to autism that he links to its rising prevalence in the country.

15/04 US CDC advisers to review vaccine guidelines after months-long delay

The U.S. Centers for Disease Control and Prevention's outside expert panel will convene on Tuesday after a nearly two-month delay and expects to review guidelines for several vaccines including recommendations for the next generation of COVID-19 shots.

14/04 Novo Nordisk warns consumers about counterfeit versions of Ozempic in US

Danish drugmaker Novo Nordisk said on Monday several hundred counterfeit units of its diabetes drug Ozempic were being distributed outside its authorized supply chain in the United States.

14/04 Pfizer ends development of weight-loss pill danuglipron

Pfizer on Monday said it has discontinued development of experimental weight-loss pill danuglipron after a trial patient experienced potential drug-induced liver injury which resolved after the medication was stopped.

14/04 Trump health policy uncertainty sends biotech sector into deeper slump

Trump administration cuts across federal health agencies have sent shivers through a biotech industry already struggling through a prolonged downturn, increasing concerns they will have a harder time getting products approved, investors, company executives and analysts said.

09/04 USDA to lose bird flu response employees, source says

Several U.S. Department of Agriculture employees who worked on the agency's bird flu response will leave at the end of April, straining the federal capacity to monitor the spread of the virus, according to a source familiar with the situation.

08/04 Measles cases in Texas rise to 505, state health department says

The Texas health department reported 505 cases of measles in the state on Tuesday, an increase of 24 cases from its previous count on April 4, as the United States battles an outbreak of the childhood disease that has spread across 22 states.

07/04 US health insurers jump as 2026 Medicare payment rates exceed expectations

The U.S. announced a 5.06% average increase in the government's final reimbursement rates for 2026 Medicare Advantage health plans run by private insurers, more than double the increase it proposed in January.

07/04 New 'surprising' case of mpox variant clade lb detected in England

Britain's health security agency said on Monday another case of the mpox variant clade lb had been detected in England in a person who had no reported travel history or link with previously confirmed cases in the country.

04/04 FDA suspends program to improve bird flu testing due to staff cuts

The U.S. Food and Drug Administration is suspending efforts to improve its bird flu testing of milk, cheese and pet food due to massive staff cuts at the agency, according to an email seen by Reuters and a source familiar with the situation.

04/04 Trump layoffs begin to erode FDA drug review system

The Trump administration's mass firings at the U.S. Food and Drug Administration have removed employees critical to reviewing new medicines, setting back years of effort to bring promising treatments to patients more quickly, former and current FDA sources told Reuters.

03/04 US health department says it may ask fired staff to keep working

Thousands of employees fired this week from the Department of Health and Human Services and the public health agencies it oversees may be asked to temporarily continue working for two months, the department said on Thursday.

02/04 FDA misses deadline for decision on Novavax's COVID-19 vaccine, source says

The U.S. Food and Drug Administration has missed the deadline for making a decision on Novavax's COVID-19 vaccine, a source familiar with the matter told Reuters on Wednesday.

02/04 US Supreme Court tosses ruling faulting FDA for denying flavored vape products

The U.S. Supreme Court threw out on Wednesday a judicial decision that found the U.S. Food and Drug Administration acted unlawfully in refusing to let two e-cigarette companies sell flavored vape products that regulators consider a health risk to youths.

02/04 US FDA insider Steele replaces Marks as top vaccine official, for now

The U.S. Food and Drug Administration said on Tuesday it had named Scott Steele as acting director of its Center for Biologics Evaluation and Research (CBER), following the exit of top vaccine scientist Peter Marks.

01/04 Analysts at Cantor, formerly headed by Lutnick, call for Kennedy's dismissal

Analysts at Cantor Fitzgerald, formerly headed by the Trump administration's Secretary of Commerce Howard Lutnick, called for the dismissal of Secretary of Health and Human Services Robert F. Kennedy Jr.

31/03 Big Tobacco targets Trump in hope - and fear - of change

Big tobacco companies like British American Tobacco are lobbying U.S. President Donald Trump's administration to crack down on illegal vapes, including via import bans on Chinese devices, documents show and industry consultants said.

31/03 Pharma stocks sink after ouster of top FDA vaccine regulator

Shares of U.S. drugmakers fell before the bell on Monday after reports that the Food and Drug Administration's top vaccine official had been forced to resign, the most high-profile exit at the regulator amid an overhaul of federal agencies.

30/03 Experimental Lilly drug cuts genetic heart disease risk factor by 94% in trial

The highest dose of an experimental drug developed by Eli Lilly significantly reduced levels of a genetically inherited risk factor for heart disease in a midstage trial, according to data presented at a major medical meeting on Sunday.

28/03 US authorizes first home test for three common sexually transmitted infections

The U.S. Food and Drug Administration on Friday granted authorization to market the first test that can be performed entirely at home for detecting three sexually transmitted infections (STIs).

28/03 US FDA declines to approve Milestone's heart rhythm nasal spray; shares halve

Milestone Pharmaceuticals said on Friday the U.S. health regulator had declined to approve its nasal spray to treat a type of heart condition and had called for an inspection of the facility that performs the testing of the drug.

28/03 EU regulator rejects Eli Lilly's Alzheimer's drug

The European Union's drugs regulator on Friday rejected Eli Lilly's Alzheimer's drug, saying the treatment's small impact on slowing cognitive decline was not large enough to outweigh the risk of serious brain swelling in patients.

27/03 Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet deadlines mandated by Congress due to Trump administration layoffs, three scientists working on the projects told Reuters.

27/03 US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome

The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, making it the first treatment available for patients who experience feelings of intense and persistent hunger.

24/03 US turns to Brazil for eggs and considers other sources during bird flu outbreak

The U.S. has almost doubled imports of Brazilian eggs once used only for pet food and is considering relaxing regulations for eggs laid by chickens raised for meat, as President Donald Trump's administration seeks to bring down sky-high prices spiked by bird flu.

10/03 Data on new Novo Nordisk obesity drug disappoints in trial, shares drop

Novo Nordisk on Monday revealed weaker-than-expected data from a second late-stage trial of its obesity drug candidate CagriSema, knocking shares and stoking worries that rival Eli Lilly may be gaining an edge over the company in the weight-loss drugs market.

06/03 US judge bars copies of Lilly weight-loss drug

A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's popular weight-loss and diabetes drugs Zepbound and Mounjaro in the United States.

25/01 Trump's Justice Department limits cases over blocked access to abortion clinics

The U.S. Justice Department's new leadership under President Donald Trump ordered cutbacks on Friday on federal prosecutions of people accused of blocking access to reproductive health centers and abortion clinics, calling such cases a "weaponization" of law enforcement.

17/01 US turkey producers should ramp up bird flu testing, USDA says

U.S. poultry producers should ramp up testing and monitoring of turkeys for bird flu before they are slaughtered to ensure the virus stays out of the food supply, the U.S. Department of Agriculture said on Friday.

17/01 US FDA approves AstraZeneca's drug for breast cancer

The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of breast cancer, the health regulator said on Friday.

17/01 Websites selling compounded weight-loss drugs fail to inform patients of risks, research shows

Websites selling compounded versions of popular weight-loss drugs from Novo Nordisk and Eli Lilly to U.S. consumers often do not inform patients of the risks associated with these medicines, according to a research letter published on Friday.

16/01 US bans use of Red No.3 dye in food, drugs over potential cancer links

The U.S. on Wednesday banned the use of a synthetic food dye that gives some candies, cakes and certain oral medications a cherry-red color, following evidence that the dye causes cancer in laboratory rats.

16/01 Outgoing FDA chief flags online weight loss drug dangers

Current laws and regulations are not enough to protect Americans from the risks of compounded versions of popular weight loss drugs, especially those bought online, outgoing U.S. Food and Drug Administration Commissioner Robert Califf said on Thursday.

08/01 J&J pauses rollout of heart device in the US to investigate stroke risk

Johnson & Johnson said on Wednesday it has temporarily paused the rollout of its Varipulse heart device in the United States, citing an abundance of caution as the company investigates four reported stroke events.

08/01 Industry groups sue over Biden ban on medical debt from credit reports

Two groups representing the credit reporting and credit union industries have filed a lawsuit challenging a new rule adopted by U.S. President Joe Biden's outgoing administration banning the inclusion of medical debt in American consumers' credit reports.

06/01 FDA seeks to boost accuracy of blood-oxygen monitors across skin tones

The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their performance across skin tones amid growing evidence that the current ones are not reliable for patients with darker skin.

03/01 California targets ultra-processed foods in new health initiative

California Governor Gavin Newsom on Friday issued an executive order aiming to crack down on ultra-processed foods including packaged snacks and sugary beverages, and further investigate the health effects of synthetic food dyes.

31/12 Merck wins UK approval for lung disease drug acquired in $11 bln deal

UK's Medicines and Healthcare products Regulatory Agency said on Tuesday it had approved Merck's therapy to treat a rare lung condition, marking another win for the drugmaker's potential blockbuster.

24/12 US FDA revokes authorization for four COVID antibody drugs

The U.S. Food and Drug Administration has revoked the emergency use authorization for four COVID-19 antibody-based drugs, including those from Eli Lilly and Regeneron .

20/12 Lilly's weight-loss treatment Zepbound becomes first FDA-approved drug for sleep apnea

The U.S. Food and Drug Administration on Friday approved Eli Lilly's weight-loss treatment, Zepbound, for obstructive sleep apnea, making it the first drug greenlighted to directly treat patients with the common sleeping disorder.

20/12 'A worst case scenario for Novo': Read the market reaction to CagriSema trial

Novo Nordisk said on Friday its experimental next-generation obesity drug CagriSema helped overweight patients cut their weight by 22.7% in a late-stage trial, below the 25% it had expected, wiping as much as $125 billion off the company's value.

20/12 Novo Nordisk's next-gen obesity drug CagriSema achieves lower weight loss than expected

Novo Nordisk said on Friday its experimental next-generation obesity drug CagriSema helped overweight patients cut their weight by 22.7% in a late-stage trial, below the 25% it had expected, sending its shares down sharply.

20/12 GSK's cancer drug combo meets main goal in ovarian cancer trial

GSK said on Friday that adding its cancer drug Jemperli to both standard-of-care chemotherapy and Zejula as a maintenance therapy improved survival in patients with advanced ovarian cancer without the disease getting worse in a late-stage trial, meeting its main goal.

20/12 US FDA approves Ionis Pharma's genetic disorder drug

The U.S. Food and Drug Administration has approved Ionis Pharmaceuticals' drug to treat a rare genetic disorder, making it the company's first wholly-owned drug, the health regulator's website showed on Thursday.

20/12 In weight loss battle, Novo and Lilly face growing offensive from licensed copies

As Novo Nordisk and Eli Lilly expand sales of their popular diabetes and weight-loss drugs, cheaper copies of their patented remedies are winning approval from some regulators overseas, posing a threat to the pharma giants' prices and market share.

18/12 US accuses CVS of filling, billing government for illegal opioid prescriptions

The U.S. Department of Justice on Wednesday announced a lawsuit accusing CVS of filling and billing federal health insurance programs for illegal opioid prescriptions, contributing to a nationwide epidemic of opioid addiction and overdose.

18/12 Pelicot rape trial shifts France's practices around drug-facilitated assaults

Around late September, staff manning the phones at 39 19, France's main anonymous hotline for women who are victims of violence, began noticing a new type of case.

18/12 Eli Lilly's Alzheimer's treatment approved in China

China's medical regulator has approved Eli Lilly's treatment for early Alzheimer's, providing patients with another option after Eisai and Biogen's Leqembi received approval in January, the company said late on Tuesday.

18/12 US FDA warns online vendors selling unapproved weight-loss drugs

The U.S. Food and Drug Administration said on Tuesday it has sent warning letters to four companies for selling unapproved versions of GLP-1 drugs including semaglutide and tirzepatide, the active ingredients in popular diabetes and weight-loss drugs.

17/12 Congo's health ministry says unknown disease is severe malaria

Democratic Republic of Congo's health ministry said on Tuesday that a previously unidentified disease circulating in the country's Panzi health zone is a severe form of malaria.

17/12 Teva, Sanofi say bowel disease drug met primary targets

Israel's Teva Pharmaceutical Industries and French drugmaker Sanofi said a study of a drug to treat ulcerative colitis and Crohn's disease showed it had met primary goals.

17/12 New HIV prevention drug could reach poorest countries by 2025, says health official

A new long-acting preventive HIV drug could reach the world’s poorest countries by the end of 2025 or early 2026, a global health official told Reuters on Tuesday.

16/12 Kennedy opposed by advocates for US health post

An expanding coalition of health and consumer advocates is campaigning against Robert F. Kennedy Jr.'s nomination to the top U.S. health job over concerns about his activism against vaccines and other health issues, according to the groups' representatives.

14/12 US FDA approves Neurocrine Biosciences' genetic disorder drug

The U.S. Food and Drug Administration has approved Neurocrine Biosciences' drug to treat a type of genetic disorder, the health regulator's website showed on Friday.

14/12 US FDA approves Checkpoint's skin cancer drug

The U.S Food and Drug Administration said on Friday it has approved Checkpoint Therapeutics' drug for treatment of a type of cancer on the outer layer of the skin.

13/12 Musk has until Monday to respond to SEC Twitter settlement, source says

The U.S. Securities and Exchange Commission has given Elon Musk until Monday to respond to an offer to resolve a probe into the billionaire's $44-billion takeover of Twitter in 2022, a source familiar with the matter told Reuters.

13/12 Consulting firm McKinsey to pay $650 mln to resolve US opioid probe

McKinsey & Co has agreed to pay $650 million to resolve a U.S. Department of Justice investigation into the consulting firm's work advising opioid manufacturer OxyContin maker Purdue Pharma on how to boost sales.

13/12 SEC 'reopens' probe into Neuralink, Musk's lawyer says

The U.S. Securities and Exchange Commission (SEC) this week has reopened an investigation into Elon Musk's brain-chip startup Neuralink, according to a letter shared by Musk on Thursday on social media platform X.

10/12 Prince Harry faces four days in witness box in Murdoch papers trial

Prince Harry could be quizzed for four days in the witness box by lawyers for Rupert Murdoch's News Group Newspapers (NGN) when his lawsuit against the publisher goes to trial next month, London's High Court was told on Tuesday.

09/12 GSK's drug combo shown to cut risk of death by 42% in type of blood cancer

British drugmaker GSK said on Monday its experimental cancer drug Blenrep in combination with other treatments reduced the risk of death by 42% in multiple myeloma, a common type of blood cancer, at or after first relapse compared to an existing treatment.

08/12 Trump aides contact Google, Meta, Snap over online drug sales, The Information reports

Snap and TikTok also were included.

05/12 FDA chief defends work on obesity, food to US Senate as agency awaits fierce critic RFK Jr

U.S. Food and Drug Administration Commissioner Robert Califf defended the agency's role in addressing the country's obesity epidemic as he was grilled by senators over FDA regulation of the food and beverage industry on Thursday.

05/12 US Supreme Court could allow broader curbs on transgender rights

During arguments at the U.S. Supreme Court in this week's major transgender rights case, liberal Justice Sonia Sotomayor told the lawyer defending Tennessee's ban on gender-affirming medical care for people under age 18 that courts have a historic role in protecting minorities from discrimination.

05/12 US FDA cited animal lab at Musk’s Neuralink for ‘objectionable conditions’

An animal testing laboratory at Elon Musk's Neuralink brain technology company was found to have "objectionable conditions or practices" by the Food and Drug Administration, which cited the company and urged it to address the problems.

05/12 FDA approves AstraZeneca's Imfinzi for limited-stage small cell lung cancer

The U.S. Food and Drug Administration has approved AstraZeneca blockbuster drug Imfinzi to treat some adults with limited-stage small cell lung cancer, the health regulator said on Wednesday.

04/12 US Supreme Court set to hear major transgender rights case

The U.S. Supreme Court is set on Wednesday to hear arguments in a major transgender rights case testing the legality of a Republican-backed ban in Tennessee on gender-affirming medical care for transgender minors, one of 24 such policies enacted by conservative state lawmakers around the country.

03/12 Unknown disease kills 143 in southwest Congo, local authorities say

An unknown disease killed 143 people in Democratic Republic of the Congo's southwestern province in November, local authorities told Reuters.

03/12 US salmonella outbreak linked to cucumbers under investigation by FDA and CDC

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are investigating a multistate outbreak of salmonella typhimurium infections linked to cucumbers, the agencies said on Monday.

29/11 Flavored vape products dispute goes before US Supreme Court

A dispute over the U.S. Food and Drug Administration's refusal to let two e-cigarette companies sell flavored vape products due to their health risk to youths goes before the U.S. Supreme Court on Monday in another case involving the power of regulatory agencies.

28/11 Transgender care at issue in US Supreme Court's latest culture war fight

Dr. Susan Lacy had been caring for transgender patients for several years in Tennessee when, in 2023, everything changed. In the span of a few months, the Republican-governed state banned healthcare providers from treating minors for gender dysphoria.

27/11 Big pharma pushes Trump team to ease Medicare drug price negotiation rules

The U.S. pharmaceutical industry is pushing to revamp the new law that allows Medicare to negotiate prices for its costliest prescription drugs once president-elect Donald Trump is back in office, according to lobbyists, executives, analysts and healthcare policy experts.

26/11 Amgen drug leads to up to 20% weight loss in trial

Amgen's experimental drug MariTide led to an average weight loss of up to 20% in a year-long mid-stage trial of nearly 600 people who were overweight or obese, the company said on Tuesday.

25/11 Musk's Neuralink to launch feasibility trial with brain implant, robotic arm

Elon Musk's brain technology startup Neuralink said on Monday it has received approval to launch a new feasibility study using its brain implant and an experimental robotic arm.

25/11 Merck's therapy for rare lung condition shown to help reduce risk of death in study

Merck said on Monday its drug, Winrevair, helped significantly reduce the risk of death in patients with a rare condition which causes high blood pressure in the lungs, months after it secured approval in the United States.

25/11 Exclusive: Thousands turn to Wegovy copies each month as FDA considers shortage status

More than 200,000 prescriptions for copies of Novo Nordisk's weight-loss drug Wegovy are getting filled by U.S. patients each month, an industry group told the U.S. drugs regulator in a letter, saying it should consider their role in alleviating the obesity drug supply crunch before barring them.

23/11 US FDA approves BridgeBio's drug for rare heart condition

The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said on Friday, making it the first new treatment in a market dominated by Pfizer's blockbuster Vyndaqel.

23/11 Trump's FDA pick is surgeon and writer Martin Makary

U.S. president-elect Donald Trump has nominated surgeon and writer Martin Makary to lead the U.S. Food and Drug Administration, the world's most influential drug regulator with a more than $7 billion budget.

22/11 Canadian neurosurgeons seek six patients for Musk's Neuralink brain study

Canadian neurosurgeons in partnership with Elon Musk's Neuralink have regulatory approval to recruit six patients with paralysis willing to have a thousand electrode contacts in their brains.

22/11 Exclusive: US FDA finds widely used asthma drug impacts the brain

U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters.

21/11 Displaced by war, cancer patients in Lebanon struggle for survival

Lebanese small business owner Ahmad Fahess thought nothing could be more devastating than his cancer diagnosis until suddenly, while he was at work one day, Israeli airstrikes started targeting his town of Nabatieh in south Lebanon.

21/11 Elon Musk's Neuralink receives Canadian approval for brain chip trial

Elon Musk's Neuralink said on Wednesday it has received approval to launch its first clinical trial in Canada for a device designed to give paralysed individuals the ability to use digital devices simply by thinking.

21/11 Trump likely to pick Johns Hopkins surgeon, COVID mandate critic Makary for FDA, sources say

U.S. President-elect Donald Trump will likely choose Johns Hopkins surgeon and writer Martin Makary to lead the Food and Drug Administration, two sources familiar with the matter told Reuters on Wednesday.

18/11 USDA confirms domestic flock infected with bird flu in Hawaii

The United States Department of Agriculture confirmed the presence of bird flu in Hawaii on Monday, the first case of the virus in a domestic flock in the state since the current outbreak began in 2022.

18/11 Lilly pill cuts genetic form of cholesterol nearly 86% in study

The highest dose of an experimental pill developed by Eli Lilly dramatically lowered an inherited form of high cholesterol in a mid-stage trial, according to data presented at a medical meeting on Monday.

18/11 Novo Nordisk has launched obesity drug Wegovy in China

Novo Nordisk said on Monday it has launched its popular obesity drug Wegovy in China, the world's second-largest pharmaceuticals market.

15/11 RFK Jr vow to purge FDA sets up collision with Big Pharma

Robert F. Kennedy Jr. vowed to purge the U.S. Food and Drug Administration shortly before being chosen as President-elect Donald Trump's nominee for health secretary. Any changes he wants to make will come up against a pharmaceutical industry that pays much of the regulator's bills.

14/11 Trump's health team: Who could be in the running?

As President-elect Donald Trump's transition team vets candidates for key healthcare positions, pharmaceutical industry sources said the following people are possible appointees:

14/11 Under Trump, US government legal stance poised to shift at Supreme Court

Republican Donald Trump's return to the presidency is expected to precipitate a shift in the U.S. government's legal stance in major cases pending at the Supreme Court, including a closely watched dispute involving Tennessee's ban on gender-affirming medical care for transgender minors.

14/11 Eli Lilly's weight-loss drug helps nearly 99% of patients remain diabetes-free

Eli Lilly said on Wednesday its weight-loss drug helped nearly 99% of patients remain diabetes-free after three years of weekly injections.

12/11 US epidemic of sexually transmitted infections shows signs of slowing, CDC says

The number of sexually transmitted infections (STI) in the United States in 2023 was down nearly 2% from the year before, a sign the epidemic could be slowing, the Centers for Disease Control and Prevention said on Tuesday.

12/11 US FDA declines full approval for Intercept's liver disease drug

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, raising questions about its future in the market.

11/11 US FDA lifts clinical hold on Novavax's combo COVID-flu shot

The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after a safety concern was found to be unrelated to the combination shot, the company said.

09/11 RFK Jr is reviewing resumes for top Trump health jobs, sources say

Robert F. Kennedy Jr, the former independent presidential candidate, is reviewing candidate resumes for the top jobs at the U.S. government's health agencies in Donald Trump's new administration, a former Kennedy aide and a source familiar with the matter told Reuters on Friday.

07/11 U.S. FDA proposes ending use of popular decongestant present in cold medicines

The U.S. Food and Drug Administration has proposed to remove oral phenylephrine, widely used in cold and cough syrups, as an active ingredient in over-the-counter drugs for nasal congestion, stating it is not effective, the health regulator said on Thursday.

06/11 Novo Nordisk aware of reports 10 people taking compounded weight-loss drug copies died

Novo Nordisk chief financial officer Karsten Munk Knudsen said on Wednesday the company was aware of reports of 10 deaths and 100 hospitalisations of people who had taken compounded copies of its weight-loss and diabetes drugs.

01/11 Novo's weight-loss drug helps improve liver fibrosis in late-stage trial

Novo Nordisk said on Friday its weight-loss drug met the main goal of a late-stage trial by showing improvement in liver fibrosis with no worsening of steatohepatitis.

01/11 Abbott, Reckitt cleared of liability in latest preterm formula case

Abbott and Reckitt unit Mead Johnson are not responsible for a young boy's debilitating intestinal disease, a jury found on Thursday in a lawsuit accusing them of failing to warn of their premature baby formulas' risks.

01/11 How Asian pharma suppliers cash in on Ozempic copies

Just over a year ago, New Zealand customs officials started to intercept batches of injectable medications labelled Fitaro and Orsema, developed by a little-known Bangladeshi drugmaker, Incepta Pharmaceuticals.

30/10 US FDA says lowest dose of Novo Nordisk's weight-loss drug now available

The lowest dose of Novo Nordisk's weight-loss drug, Wegovy, was listed as available, the U.S. health regulator's website showed on Wednesday.

30/10 $35 insulin: Who in the US benefits?

Vice President Kamala Harris on the campaign trail has frequently touted capping the price of insulin at $35 a month as a major accomplishment of the Biden administration, referring to a provision of the Inflation Reduction Act.

29/10 Japan's Shionogi says Phase 3 study showed COVID pill reduces transmission

Japan's Shionogi & Co said on Tuesday a global, late-stage study showed its pill-based treatment for COVID-19 was effective in reducing transmission of the disease.

24/10 Novo Nordisk asks US to stop compounding pharmacies from making weight-loss drug copies

Novo Nordisk on Tuesday asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too complex for those manufacturers to produce safely.

23/10 UK approves Lilly's Alzheimer's drug, but deemed 'too expensive' for wide use

Eli Lilly's treatment for early Alzheimer's was deemed too expensive for wide use by UK's cost-effectiveness body on Wednesday, signalling that patients are unlikely to get access following approval by the country's medicines regulator.

22/10 First openly transgender lawyer to argue at US Supreme Court

An American Civil Liberties Union lawyer will make history in December as the first openly transgender attorney to argue before the U.S. Supreme Court, opposing Tennessee's Republican-backed law banning gender-affirming medical care for transgender minors.

11/09 US FDA staff questions confirmatory trial data for Intercept's liver disease drug

Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the effectiveness of Intercept's liver disease drug, which received the health regulator's accelerated nod in 2016.

11/09 Novo Nordisk experimental obesity pill has mild-to-moderate side effects in trial

Novo Nordisk said on Wednesday its highly anticipated experimental weight-loss pill amycretin was safe and tolerable for patients in an early-stage trial, with mild-to-moderate side effects.

10/09 More than 49 million in US covered by ACA over the past decade

One in seven Americans have signed up for health insurance coverage through Affordable Care Act marketplaces since their 2014 launch, according to data released on Tuesday by the U.S. Department of the Treasury.

03/09 Nvidia-backed Recursion's shares fall on mixed data for rare disorder drug

Nvidia-backed Recursion Pharmaceuticals said on Tuesday its experimental drug to treat a rare brain-related condition was safe and tolerable in a mid-stage study, but showed mixed results for efficacy.

03/09 Novo Nordisk's Ozempic shortage expected to continue into Q4

Novo Nordisk said the shortage of lower strengths of its diabetes drug Ozempic has deteriorated, with intermittent shortages for all strengths expected into the final quarter of 2024 due to increased demand and along with capacity constraints at some of its manufacturing sites.

30/08 FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain

The U.S. Food and Drug Administration on Friday granted emergency use authorization for an updated version of Novavax's COVID shot.

30/08 Mpox vaccines to arrive in DR Congo in next few days, WHO says

The World Health Organization chief said on Friday that mpox vaccines were set to arrive in the Democratic Republic of Congo in the next few days to fight a new strain of the virus.

30/08 US tests for bird flu in California dairy cattle

The U.S. Department of Agriculture is testing to confirm possible cases of bird flu in dairy cattle in California, the nation's biggest milk-producing state, USDA said on Friday.

30/08 Emergent Bio's smallpox vaccine gets US approval for mpox

The U.S. Food and Drug Administration granted expanded approval to Emergent BioSolutions' smallpox vaccine for use in people at high risk of mpox infection, sending the drugmaker's shares 5% higher on Friday.

29/08 Smokers under 30 need photo IDs to buy tobacco products, US FDA says

The U.S. Food and Drug Administration has mandated more people show photo identification when buying tobacco products, as the health regulator raised the age verification requirement by three years.

29/08 Biden cap on drug costs will save US seniors over $1,000 a year, study finds

More than 1 million people in the U.S. will save over $1,000 a year beginning in 2025, when an annual $2,000 cap on prescription drug out-of-pocket costs kicks in, the leading lobbying group for older Americans said on Wednesday.

24/08 US FDA classifies recall of Inari's catheter devices as 'most serious'

The U.S. Food and Drug Administration on Friday classified a recall of Inari Medical's ClotTriever catheter that helps capture and remove large clot from big vessels as "most serious".

23/08 Ozempic on Wall Street's list for 2027 Medicare drug negotiations

Now that the U.S. government has negotiated prices for some Medicare program drugs effective in 2026, Wall Street analysts are betting on a 2027 list that will include Novo Nordisk's blockbuster Ozempic for diabetes and have a limited impact on Big Pharma.

22/08 US FDA approves updated COVID shots ahead of fall and winter

The U.S. Food and Drug Administration on Thursday approved updated COVID-19 vaccines made by Pfizer and Moderna targeting a recent variant of the disease, in time for a fall vaccination campaign.

22/08 New Alzheimer's drug deemed too costly for UK's state-run health service

Alzheimer's patients in Britain's state-run health service are unlikely to get access to Eisai and Biogen's new Leqembi drug, after it was approved on Thursday by the country's regulator but deemed too expensive for wide use.

20/08 U.S. clinical trials in China questioned by U.S. lawmakers

A bipartisan group of lawmakers on Tuesday called on the Biden administration to ramp up scrutiny of U.S. clinical trials conducted in China, citing the risk of intellectual property theft and the possibility of forced participation of Uyghurs.

16/08 EU public health body lifts mpox risk alert level

The European Centre for Disease Prevention and Control (ECDC) on Friday raised its risk level for mpox, a day after global health officials confirmed the first infection with a new strain of the virus outside Africa, in Sweden.

16/08 EU public health body lifts mpox risk alert level after new strain found in Sweden

The European Centre for Disease Prevention and Control on Friday raised its risk level for mpox, a day after global health officials confirmed one case of infection with a new strain of the virus in Sweden, the first outside Africa.

16/08 European CDC raises mpox risk alert level

The European Centre for Disease Prevention and Control (CDC)raised its risk alert level for mpox on Friday, and asked countries to maintain high levels of awareness among travellers visiting from affected areas.

15/08 AstraZeneca's Imfinzi gets FDA priority review for type of lung cancer

AstraZeneca said on Thursday the U.S. Food and Drug Administration (FDA) has granted its blockbuster cancer drug Imfinzi a priority review for patients with limited-stage small cell lung cancer in the United States.

10/08 US FDA declines to approve first MDMA-based PTSD treatment

Commonly known as ecstasy or molly, MDMA has long been seen by advocates as a potential treatment for mental-health disorders and to have therapeutic applications beyond its illicit use.

09/08 US FDA approves first nasal spray for allergic reactions

The U.S. Food and Drug Administration has approved ARS Pharmaceuticals' nasal spray as the first needle-free emergency treatment for potentially fatal allergic reactions, the regulator said on Friday.

09/08 US FDA approves Citius' therapy for rare blood cancer

The U.S. Food and Drug Administration has approved Citius Pharmaceuticals' therapy for patients with a form of blood cancer who have received at least one prior treatment, the company said on Thursday, an year after the regulator rejected the treatment.

07/08 US FDA approves Novartis' kidney disease drug

The U.S. Food and Drug Administration has approved the use of Novartis' drug to reduce excess protein in the urine of patients with a type of kidney disease, the health regulator's website showed on Wednesday.

07/08 US FDA approves Servier's brain tumor treatment

Servier Pharmaceuticals said on Tuesday the U.S. Food and Drug administration has approved the French drugmaker's treatment for a type of brain tumor, making it the first drug to get a U.S. approval for the condition.

03/08 US FDA approves Adaptimmune's therapy for rare type of cancer

The U.S. Food and Drug Administration said on Friday it has approved Adaptimmune's first-of-its-kind treatment for a rare type of cancer in the soft tissues that most often affects young people.

11/07 Musk's Neuralink says tiny wires of brain chip in first patient now stable

The tiny wires of Neuralink's brain chip implant used in the first participant in a trial run by Elon Musk's company have become "more or less very stable", a company executive said on Wednesday.

10/07 Bird flu strains: Where are they spreading around the globe?

Avian influenza, or bird flu, has public health officials on alert after an unprecedented spread in dairy cows in the United States this year. Four dairy workers have also tested positive in the country.

09/07 Middlemen have outsized influence on US drug prices due to market consolidation, FTC says

The consolidation of pharmacies and health insurance companies through years of deal making has led to a handful of pharmacy benefit managers exercising outsized influence over prescription drug prices, the U.S. Federal Trade Commission said on Tuesday.

09/07 Novo Nordisk shares down after analysis finds Lilly drug leads to better weight loss

Shares in Novo Nordisk , maker of the wildly popular obesity drug Wegovy, were down 1.1% on Tuesday after the publication of a data analysis showing rival Eli Lilly's own treatment Mounjaro leads to faster and greater weight loss.

05/07 Roche to halt trial in latest setback for lung cancer immunotherapy

Roche will end a lung cancer trial testing its new immunotherapy after the drug did not show a benefit over established treatment Keytruda by Merck & Co , casting further doubt on the drug candidate pioneered by the Swiss company.

03/07 Eli Lilly Alzheimer's drug approved by US FDA

The U.S. Food and Drug Administration on Tuesday approved Eli Lilly's treatment for early Alzheimer's, making it the second therapy for slowing progression of the brain-wasting disease that will be available to U.S. patients.

02/07 India panel urges drug regulator to approve Lilly's obesity drug Mounjaro

An Indian government-approved expert panel has advised the country's drug regulator to approve the import and sale of U.S. drugmaker Eli Lilly's Mounjaro, a blockbuster diabetes drug and a wildly popular obesity treatment, a document on a government website showed on Monday.

27/06 US Supreme Court ruling on emergency abortions offers no clarity for states

The U.S. Supreme Court's ruling on Thursday allowing abortions for women facing medical emergencies in Idaho - for now - despite the state's near-total ban on the procedure does nothing to lift the confusion in many states surrounding when emergency abortions are permissible, according to legal experts.

27/06 US FDA declines to approve Merck-Daiichi's 'guided missile' cancer drug

The U.S. Food and Drug Administration declined to approve Merck and Japan-based Daiichi Sankyo's lung cancer treatment, which belongs to a lucrative class of cancer therapies that work like "guided missiles".

27/06 US Supreme Court allows emergency abortions in Idaho for now

The U.S. Supreme Court ruled on Thursday to permit - for now - abortions to be performed in Idaho when pregnant women are facing medical emergencies, as the justices dispensed with the contentious issue without actually deciding the case on its merits.

26/06 US FDA approves Verona Pharma's therapy for 'smoker's lungs'

The U.S. Food and Drug Administration has granted approval for a treatment from Verona Pharma for a chronic lung disease that commonly affects smokers, the U.K.-based company said on Wednesday.

26/06 US FDA recommends steps to improve diversity in clinical trials

The U.S. Food and Drug Administration on Wednesday recommended steps for drugmakers and medical device makers to improve racial, ethnic and other diversity in their clinical trials.

25/06 US food safety regulators expand bird flu testing in milk products

The U.S. Food and Drug Administration has begun testing more dairy products for evidence of the bird flu virus as outbreaks spread among dairy herds across the country.

25/06 AstraZeneca's Imfinzi fails in late-stage trial to treat certain lung cancers

AstraZeneca's blockbuster cancer drug Imfinzi has failed as a follow-up therapy to improve disease-free survival in a late-stage trial in patients with a type of early-stage lung cancer, the group said on Tuesday.

25/06 European shares fall as Airbus hammers aerospace shares, tech slips

European shares declined on Tuesday as Airbus tumbled after a profit warning and dragged down aerospace-related stocks, while technology shares slumped tracking the overnight selloff on Wall Street.

25/06 US Supreme Court to hear challenge to ban on transgender care for minors

The U.S. Supreme Court agreed on Monday to decide the legality of a Republican-backed ban in Tennessee on gender-affirming medical care for transgender minors, as the justices waded into another contentious issue implicating LGBT rights.

24/06 Teva launches generic version of Novo Nordisk's diabetes drug Victoza

Teva Pharmaceuticals said on Monday it had launched a generic version of Novo Nordisk's Victoza to treat patients with type 2 diabetes, making it the first generic GLP-1 drug in the United States where the drug class has seen overwhelming demand.

24/06 Novo's Wegovy induces higher weight loss in women than men with same heart condition, study shows

Novo Nordisk's popular obesity drug Wegovy helped women with a common heart disease lose more weight than men who had the same condition, an analysis of study data published in a medical journal has shown.

22/06 Appeals court does not block US mandate to cover cancer screenings, HIV drugs

A U.S. appeals court on Friday refused to block a federal mandate requiring health insurers to cover preventive care services like cancer screenings and HIV-preventing medication at no extra cost to patients, but ruled against the government on a key legal issue that leaves the mandate's future in doubt.

21/06 US FDA approves expanded use of Sarepta's Duchenne gene therapy; shares jump

The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics' gene therapy for patients with Duchenne muscular dystrophy aged four and older on Thursday, sending the company's shares up 36% in extended trading.

20/06 Gilead's long-acting HIV drug superior to daily pill Truvada in study

Gilead Sciences said on Thursday a late-stage study showed its injectable drug was more effective in preventing HIV infection in women compared to the company's existing daily pill Truvada.

20/06 WHO issues warnings on fake diabetes and weight-loss drugs

The World Health Organization (WHO) on Thursday issued warnings on falsified semaglutides used in diabetes and weight-loss drugs in light of three altered batches of products detected in Brazil, the UK and the United States.

20/06 Lilly files more lawsuits to curb sales of counterfeit Mounjaro

U.S. drugmaker Eli Lilly said on Thursday it was suing six more entities including medical spas and wellness centers for selling products claiming to contain tirzepatide, the active ingredient in its popular diabetes drug, Mounjaro.

18/06 AstraZeneca's breast cancer drug combination fails in late-stage trial

AstraZeneca said on Tuesday its breast cancer drug, Truqap, in combination with chemotherapy agent, paclitaxel, did not meet its main goals in a late-stage trial to improve overall survival of patients with a type of breast cancer.

18/06 US FDA approves Merck's pneumococcal vaccine for adults

Merck said on Monday the U.S. Food and Drug Administration has approved its next-generation vaccine to protect adults against pneumococcal disease.

17/06 Takeda's seizure drug fails to meet main goal in late-stage studies

Japanese drugmaker Takeda said on Monday its experimental drug being tested for two epileptic disorders failed to reduce frequency of seizures in patients across late-stage studies.

17/06 Explainer: What other health conditions might weight-loss drugs treat?

Novo Nordisk's blockbuster diabetes drug Ozempic and weight-loss therapy Wegovy are being studied to see whether they can improve health in other ways.

17/06 Chinese drugmakers developing generic drugs of Novo Nordisk's Ozempic

At least 11 generic versions of Novo Nordisk's popular diabetes drug Ozempic are in the final stages of clinical trials in China, as developers seek to profit from an early patent expiry of the therapy's active ingredient semaglutide in China.

17/06 Abortion rights: Tracking state lawsuits two years after Roe reversal

Nearly two years after the U.S. Supreme Court overturned its landmark 1973 ruling in Roe v. Wade, litigation over abortion has exploded.

13/06 Supreme Court's Thomas questions ability of groups to challenge US laws

Conservative Justice Clarence Thomas called on the U.S. Supreme Court on Thursday to reconsider a precedent established in 1977 that has allowed advocacy groups, trade associations and other organizations to routinely bring court challenges to government policies on behalf of their members.

13/06 Abortion pill still under legal threat despite US Supreme Court ruling

The U.S. Supreme Court's ruling on Thursday keeping the abortion drug mifepristone on the market with no new restrictions ends one chapter of the legal fight over the drug, but efforts by abortion opponents to restrict its use may not be over.

13/06 Pfizer's Duchenne gene therapy fails in late-stage study

Pfizer said on Wednesday its experimental gene therapy for Duchenne muscular dystrophy (DMD) failed to improve the motion function of patients in a late-stage trial compared with a placebo.

12/06 Explosive cases flow to US Supreme Court from 'bold' regional court

When three conservative judges sitting on a New Orleans-based U.S. appeals court declared the funding mechanism approved by Congress for the federal consumer financial watchdog agency unconstitutional, they said the nation's history of separating powers among the branches of government compelled their ruling.

12/06 US health dept lets UnitedHealth notify victims of data breach, WSJ reports

The U.S. Department of Health and Human Services (HHS) has agreed to allow UnitedHealth Group to notify people whose data was exposed during a hack on its Change Healthcare unit in February, the Wall Street Journal reported on Wednesday.

11/06 Latest trial over Zantac cancer claims called off as plaintiff drops case

A woman who claimed in a lawsuit that GSK's discontinued heartburn drug Zantac caused her breast cancer dropped her case shortly before it was set to go to trial in Illinois state court on Monday, the company announced.

10/06 US FDA grants accelerated approval to Genfit and Ipsen's liver disease drug

The U.S. Food and Drug Administration has granted accelerated approval to French drugmakers Ipsen and Genfit's drug to treat a chronic inflammatory liver disease, Ipsen said on Monday.

10/06 Hunter Biden evidence 'ugly,' prosecutors tell jury and urge conviction

The evidence against U.S. President Joe Biden’s son was grim but established that he was guilty of making a false statement about his use of illegal drugs on a background check form when he bought a gun, a government lawyer told a jury on Monday.

10/06 FDA panel to review Eli Lilly Alzheimer's drug ahead of agency decision

Outside advisers to the U.S. Food and Drug Administration will meet on Monday to discuss whether Eli Lilly's experimental Alzheimer's drug donanemab is safe and effective, ahead of the agency's decision on approving the drug.

08/06 US FDA expands GSK's RSV vaccine approval to adults aged 50 to 59

The U.S. Food and Drug Administration approved the expanded use of GSK's respiratory syncytial virus (RSV) vaccine on Friday in adults aged between 50 and 59, making it the first shot endorsed for that age group.

07/06 Pfizer's Paxlovid fails as 15-day treatment for long COVID, study finds

A 15-day course of Pfizer's COVID-19 antiviral treatment Paxlovid did not relieve symptoms of long COVID, according a study by Stanford University researchers.

07/06 Hunter Biden's daughter testifies at his criminal gun trial

Hunter Biden's daughter testified in her father's defense on Friday that he seemed to respond well to drug treatment in the weeks before he bought a gun that prosecutors say he obtained illegally by failing to disclose his addiction.

07/06 Geron surges after winning first US FDA approval for blood disorder drug

Shares of Geron surged more than 30% on Friday, a day after the company gained its first approval from the U.S. Food and Drug Administration for its blood disorder drug.

06/06 US FDA staff raise no major concerns about Eli Lilly Alzheimer's drug

An FDA analysis of trial data for Eli Lilly's experimental Alzheimer's drug donanemab released on Thursday revealed no red flags, but raised questions about safety of the treatment for patients with early-stage disease.

06/06 US FDA warns on risks linked to sulfite-containing compounded drugs

The U.S. Food and Drug Administration said on Wednesday it had alerted healthcare professionals, drug compounders and patients about the risk of allergic reactions to sulfite-containing compounded drugs.

06/06 Focus: Novo Nordisk braces for generic challenge to Ozempic, Wegovy in China

Novo Nordisk is facing the prospect of intensifying competition in the promising Chinese market where drugmakers are developing at least 15 generic versions of its diabetes drug Ozempic and weight loss treatment Wegovy, clinical trial records showed.

05/06 US Senate to vote on contraception bill in Democratic push on reproductive rights

A bill to safeguard access to contraceptives faces a U.S. Senate vote on Wednesday, part of a push by congressional Democrats to focus public attention on reproductive rights ahead of the November election but with little chance of passage.

04/06 FDA panel to review psychedelic drug MDMA for first time

A panel of advisers to the U.S. Food and Drug Administration will meet on Tuesday to discuss a therapy based on the psychedelic drug MDMA for patients with post-traumatic stress disorder (PTSD).

02/06 GSK blood cancer drug nearly halves risk of death in late-stage trial

GSK's multiple myeloma drug Blenrep nearly halved the risk of disease progression or death compared to standard-of-care treatments for the incurable blood cancer, according to data from a late-stage study presented at a medical meeting on Sunday.

01/06 Delaware judge lets more than 70,000 Zantac lawsuits go forward

A Delaware judge has allowed more than 70,000 lawsuits over discontinued heartburn drug Zantac to go forward, ruling that expert witnesses can testify in court that the drug may cause cancer.

31/05 US FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label

The U.S. Food and Drug Administration approved Moderna's respiratory syncytial virus (RSV) vaccine, the company announced on Friday, giving it a shot at much-needed new revenue from a second product.

30/05 Israel denounced over Gaza health emergency at WHO meeting

More than 30 countries condemned Israel's attacks on hospitals in Gaza and demanded more scrutiny of its role in the enclave's health crisis at a World Health Organization meeting on Wednesday, and some blamed Israel for a growing risk of famine.

29/05 Exclusive: Nicotine-like chemicals in U.S. vapes may be more potent than nicotine, FDA says

Nicotine alternatives used in vapes being launched in the U.S. and abroad, such as 6-methyl nicotine, may be more potent and addictive than nicotine itself, though the scientific data remains incomplete, according to the U.S. Food and Drug Administration (FDA) and independent researchers.

29/05 US FDA approves Amgen's biosimilar to AstraZeneca's rare blood disorder treatment

The U.S. Food and Drug Administration approved on Tuesday Amgen's Bkemv, the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris.

28/05 Musk's Neuralink registers brain implant study on US government database

Elon Musk's brain-chip startup Neuralink has registered details about a study evaluating its device in patients on the U.S. government's database of clinical trials.

25/05 Explainer: What does Louisiana's new abortion pill law mean for patients?

The Louisiana Senate's vote on Thursday to reclassify the two drugs used in medication abortion as controlled substances marks the latest development in a nationwide battle over abortion pills.

25/05 Louisiana governor signs bill classifying abortion pills as controlled substances

Louisiana's governor on Friday enacted a bill making his state the first in the U.S. to classify two abortion-inducing medications as controlled substances, a category that healthcare regulators typically reserve for drugs that may be abused or cause addiction.

24/05 Louisiana lawmakers vote to reclassify abortion pills as controlled substances

The Louisiana Senate gave final legislative approval on Thursday to a bill that would make the state the first in the U.S. to reclassify two abortion-inducing drugs as controlled substances that carry the potential for abuse or addiction.

22/05 US FDA staff flags risk of low blood sugar for Novo Nordisk's weekly insulin

The U.S. Food and Drug Administration's staff said on Wednesday the use of Novo Nordisk's long-acting weekly insulin had an increased risk of low blood sugar in patients with type 1 diabetes, who are more insulin-dependent.

20/05 US FDA tested retail milk samples for bird flu in 17 states

The U.S. Food and Drug Administration said on Monday that it tested retail samples of milk and other dairy products in 17 states for viable bird flu virus, providing further details about the locations of the previously disclosed tests.

20/05 US FDA clears Neuralink's brain chip implant in second patient, WSJ reports

The U.S. Food and Drug Administration has allowed billionaire Elon Musk's Neuralink to implant its brain chip in a second person after the company offered fixes to a problem that occurred in the first patient, the Wall Street Journal reported on Monday.

16/05 Properly cooked hamburgers pose no bird flu risk, US study finds

No bird flu virus was found after cooking ground beef to medium to well done, the U.S. Department of Agriculture said in a briefing on Thursday after conducting a study as it addresses concerns over an outbreak of the disease in dairy cattle.

16/05 US unveils proposal to ease restrictions on marijuana

The U.S. Justice Department on Thursday unveiled a historic proposal to ease restrictions on marijuana, a rule that if enacted would also enable more research on its medicinal benefits.

15/05 Jury chosen for US Senator Menendez's corruption trial

A jury was chosen on Wednesday to determine whether Democratic U.S. Senator Robert Menendez broke the law in what federal prosecutors have called a years-long bribery scheme to benefit the governments of Egypt and Qatar, as well as himself.

15/05 Exclusive: Musk's Neuralink has faced issues with its tiny wires for years, sources say

Neuralink's disclosure last week that tiny wires inside the brain of its first patient had pulled out of position is an issue the Elon Musk company has known about for years, according to five people familiar with the matter.

14/05 US Senator Robert Menendez goes on trial for corruption, no jurors chosen

Jury selection began in the corruption trial of U.S. Senator Robert Menendez on Monday, with a judge excusing dozens of prospective jurors in a case that could affect the Democrat's political future and the makeup of the U.S. Senate.

13/05 Before global scrutiny, Indian spice maker MDH faced many US rejections

Popular Indian spice brand MDH, under scrutiny for alleged contamination in some products, has since 2021 seen an average 14.5% of its U.S. shipments rejected due to the presence of bacteria, a Reuters analysis of U.S. regulatory data found.

08/05 US FDA advises healthcare facilities to switch from Getinge's heart devices

The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart devices in patients as they faced safety and quality concerns despite a string of recalls.

07/05 US FDA panel to discuss first psychedelic-assisted PTSD treatment next month

The U.S. FDA's panel of independent advisers will on June 4 deliberate whether they should recommend approval for the first MDMA-assisted therapy for post-traumatic stress disorder, Lykos Therapeutics said on Monday.

03/05 Amgen jumps after teasing weight-loss drug data, rival stocks fall

Amgen shares headed for their best session since 2009 on Friday after the U.S. drugmaker hinted at encouraging interim trial data on its experimental obesity drug, denting rival stocks but leaving analysts frustrated with a lack of details.

01/05 Bird flu testing shows more dairy products are safe, US FDA says

The U.S. Food and Drug Administration said on Wednesday that preliminary results of additional testing of more dairy products has shown that pasteurization inactivates the bird flu virus.

01/05 U.S. military personnel had data stolen in UnitedHealth hack, CEO tells Senate

Members of the U.S. military have had their data stolen in the recent cyberattack on UnitedHealth's technology unit that impacted almost all patients and providers, CEO Andrew Witty told the Senate Finance Committee on Wednesday.

30/04 Eli Lilly lifts profit view on diabetes and weight-loss drug strength

Eli Lilly on Tuesday raised its full-year profit forecast, betting on surging demand for its weight-loss treatment Zepbound and type 2 diabetes drug Mounjaro.

30/04 J&J, Bristol Myers lose challenges to US drug price negotiation program

A U.S. judge on Monday rejected a challenge by Bristol Myers Squibb and Johnson & Johnson to a law requiring them to negotiate the prices of their blockbuster blood clot prevention drugs with the U.S government's Medicare health insurance program or pay heavy penalties.

27/04 US food regulator gathering information on Indian spices after alleged contamination

The U.S. Food and Drug Administration (FDA) is gathering information on products of Indian spice makers MDH and Everest after Hong Kong halted sales of some of their products for allegedly containing high levels of a cancer-causing pesticide.

26/04 US FDA approves Pfizer's gene therapy for rare bleeding disorder

The U.S. Food and Drug Administration approved Pfizer's gene therapy for hemophilia B on Friday, the second such therapy for the rare bleeding disorder that typically requires regular infusions of a blood-clotting protein.

24/04 US Senate committee investigates pricing of Novo's Ozempic and Wegovy

A U.S. Senate committee said on Wednesday it had launched an investigation into the prices of Novo Nordisk's diabetes and weight loss drugs Ozempic and Wegovy in the United States.

24/04 Medicare beneficiaries could be eligible for Wegovy coverage, study shows

About 3.6 million overweight or obese patients with heart conditions insured under the U.S. Medicare program could be eligible for coverage of Novo Nordisk's weight-loss drug Wegovy, a study published by Kaiser Family Foundation (KFF) showed on Wednesday.

24/04 US Supreme Court weighs Idaho's strict abortion ban in medical emergencies

The U.S. Supreme Court on Wednesday wades back into the battle over abortion access in arguments pitting Idaho's strict Republican-backed abortion ban against a federal law that ensures that patients can receive emergency care.

23/04 US Supreme Court faces fight over emergency abortions after toppling Roe

The idea of a doctor in the United States having to consider the risk of imprisonment before performing an emergency abortion might have been difficult to imagine just two years ago.

23/04 UnitedHealth says hackers possibly stole large number of Americans' data

UnitedHealth Group said on Monday that hackers stole health and personal data of potentially a "substantial proportion" of Americans from its systems in February, as the largest U.S. health insurer scrambles to contain the damage.

19/04 WHO says wider alert on contaminated J&J cough syrup 'likely'

The World Health Organization is likely to issue a wider warning about contaminated Johnson and Johnson-made children's cough syrup found in Nigeria last week, it said in an email.

18/04 Dengue cases surge near 50% in the Americas amid 'emergency situation'

Dengue cases have created an "emergency situation" in the Americas, although cases in hotspots Argentina and Brazil appear to have stabilized, the head of the Pan American Health Organization (PAHO) said on Thursday.

17/04 Most doses of Lilly's Mounjaro and Zepbound in limited availability, US FDA says

The U.S. Food and Drug Administration website showed that most doses of Eli Lilly's diabetes drug Mounjaro and weight-loss drug Zepbound would be available in limited amounts through the second quarter of this year due to increased demand.

17/04 Lilly's weight-loss drug reduces sleep apnea severity in late-stage studies

Eli Lilly said on Wednesday its weight-loss drug helped reduce episodes of irregular breathing in patients with obstructive sleep apnea across two late-stage trials.

15/04 Tanzania, Rwanda join African recall of J&J children's cough syrup

Drug regulators in Tanzania and Rwanda have recalled a batch of Johnson & Johnson children's cough syrup as a precautionary measure after their Nigerian counterpart said laboratory tests found high levels of toxicity.

13/04 South Africa recalls J&J's cough syrup sold in six African nations after suspected toxicity

South Africa's health regulator said on Saturday it is recalling batches of Johnson & Johnson's children's cough syrup after detection of high levels of diethylene glycol.

12/04 EU regulator rules out link between weight-loss drugs and suicidal thoughts

The European Union drug regulator found no evidence that a class of diabetes and weight-loss drugs such as Novo Nordisk's hugely popular Wegovy, are linked to suicidal thoughts, it said on Friday, ending a nine-month probe.

11/04 Kenya recalls J&J children's cough syrup over suspected toxicity

Kenya's drug regulator is recalling a batch of Johnson & Johnson children's cough syrup, it said on Thursday, a day after Nigeria recalled the same batch of medication under the Benylin Paediatric brand.

10/04 Nigeria recalls J&J children's cough syrup over toxic substance

Nigeria's health regulator is recalling a batch of Johnson & Johnson children's cough syrup after finding an unacceptably high level of a potentially fatal toxic substance, it said on Wednesday.

09/04 US FDA declines to approve Supernus' Parkinson's combination again

Supernus Pharmaceuticals said on Monday the U.S. FDA declined to approve its drug-device combination to treat movement-related symptoms of Parkinson's disease, sending its shares down 9% in early trade.

08/04 Exclusive: Synchron, a rival to Musk’s Neuralink, readies large-scale brain implant trial

Synchron Inc, a rival to Elon Musk's Neuralink brain implant startup, is preparing to recruit patients for a large-scale clinical trial required to seek commercial approval for its device, the company's chief executive told Reuters.

05/04 US FDA approves Daiichi, AstraZeneca drug for treatment of solid tumors

The U.S. Food and Drug Administration on Friday gave accelerated approval for the expanded use of Daiichi Sankyo and AstraZeneca's drug to treat patients with a type of solid tumor.

05/04 US FDA allows expanded use of Bristol Myers' cell therapy for blood cancer

The U.S. Food and Drug Administration on Friday allowed the use of Bristol-Myers Squibb and 2seventybio's cell therapy Abecma in less severely affected patients with a type of blood cancer.

05/04 AstraZeneca's Imfinzi shows promise in treating aggressive lung cancer

Drugmaker AstraZeneca said on Friday its blockbuster cancer drug Imfinzi showed "significant and clinically meaningful" improvement in the primary goals of a late-stage trial designed for an aggressive type of lung cancer.

05/04 US FDA issues warning letters to retailers against underage sale of ZYN nicotine pouches

The U.S. Food and Drug Administration on Thursday said it had issued warning letters and filed civil money penalty complaints against retailers engaged in underage sale of various flavors of ZYN nicotine pouches.

03/04 Lilly's weight-loss drug Zepbound to face supply crunch through April-end, US FDA says

Two doses of Eli Lilly's weight-loss drug Zepbound are expected to remain in short supply through April-end, the U.S. Food and Drug Administration's website showed on Wednesday, as demand for the powerful obesity drug soars.

03/04 China's first biosimilar Ozempic drug applies for approval

A Chinese drugmaker has developed a biosimilar version of Novo Nordisk's popular diabetes drug Ozempic and applied for its approval.

28/03 Dengue cases surge in the Americas in potentially worst-ever outbreak -PAHO

Dengue cases in the Americas spiked in the first three months of this year by three times the number of infections reported in the same period last year, the Pan American Health Organization said on Thursday.

26/03 Biden administration defends abortion pill access at US Supreme Court

The U.S. Supreme Court on Tuesday is poised to consider whether to restrict access to the abortion pill as President Joe Biden's administration fights to maintain broad access to the medication in a major case that thrusts reproductive rights back on the agenda of the justices in a presidential election year.

26/03 Exclusive: US lawmaker seeks answers on FDA inspection of Musk's Neuralink

A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk's Neuralink before allowing the brain implant company to test its device in humans.

23/03 US FDA grants full approval to AbbVie's ovarian cancer therapy

The U.S. Food and Drug Administration said on Friday it had granted traditional approval for AbbVie's "guided missile" cancer therapy, Elahere, for patients with a type of ovarian cancer.

22/03 Measles cases in US rise to 62 as of Thursday, says CDC

The U.S. Centers for Disease Control and Prevention (CDC) said on Friday the number of measles cases in the United States has increased to 62 as of Thursday, higher than the whole of last year.

21/03 Wegovy to be covered by US Medicare for heart disease patients

Heart patients insured under the U.S. Medicare program would be covered for Novo Nordisk's weight-loss drug Wegovy as long as it is prescribed to reduce their risk of heart attacks and strokes, the agency overseeing the program said on Thursday.

18/03 Biden pushes for expansion in women's health research

President Joe Biden will issue an executive order on Monday expanding U.S. government research on women's health, while spending $200 million next year to better understand issues including sexual and reproductive conditions.

17/03 Chemicals in plastics far more numerous than previous estimates, report says

At least 3,000 more chemicals are in plastics — from food packaging to toys to medical devices — than previously estimated by environmental agencies, a report published on Thursday found, raising questions over pollution and consumer safety.

16/03 US FDA panel backs expanded use of J&J, Bristol Myers' CAR-T therapies

Advisers to the U.S. health regulator voted in favor of allowing the use of Johnson & Johnson and Bristol Myers Squibb's cell therapies as earlier treatments on Friday, paving the way for their use in less severely affected patients with a type of blood cancer.

16/03 US agency urges interim payments for healthcare providers hit by UnitedHealth hack

The U.S. government said on Friday it has urged states to make interim payments to healthcare providers that were hit by the cyberattack at UnitedHealth's unit Change Healthcare.

15/03 Merck's Keytruda combo succeeds in late-stage trial for cervical cancer treatment

Merck said on Friday its blockbuster immunotherapy Keytruda, in combination with chemoradiotherapy, met the main goal of improving overall survival for newly diagnosed patients with a form of cervical cancer in a late-stage study.

15/03 US FDA approves first drug for fatty liver disease NASH

The U.S. FDA has approved Madrigal Pharmaceuticals' drug for a fatty liver disease known as non-alcoholic steatohepatitis (NASH), the first treatment to get the nod for the condition and opening up a multi-billion dollar opportunity.

15/03 US FDA expands use of Bristol Myers' cancer therapy

The U.S. Food and Drug Administration on Thursday expanded the use of Bristol Myers Squibb's cell therapy, Breyanzi, for a type of slow-growing blood cancer, marking the second approval for the treatment.

14/03 US FDA approves expanded use of Mirum's liver disease drug

The U.S Food and Drug Administration has approved the expanded use of Mirum Pharmaceuticals' oral drug to treat itching caused by a liver disorder in patients aged five years and older, the company said on Wednesday.

13/03 US FDA staff flag safety concerns from J&J, Bristol's CAR-T therapies

The U.S. Food and Drug Administration's staff reviewers on Wednesday raised safety concerns over the use of Johnson & Johnson's and Bristol-Myers Squibb's cancer therapies as earlier treatments for blood cancer patients.

13/03 Merck to test single-dose regimen of HPV vaccine Gardasil 9

Merck & Co said on Wednesday it plans to conduct clinical trials testing its human papillomavirus (HPV) vaccine Gardasil 9 to evaluate the efficacy and safety of a single-dose regimen compared to the approved three-dose regimen.

12/03 US FDA staff raises concerns on Geron's blood disorder drug

The U.S. Food and Drug Administration's staff reviewers said on Tuesday they were unclear if Geron's blood disorder drug provided a clear benefit to patients in a late-stage trial and raised multiple safety concerns with the treatment.