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FDA PANEL MEETING
FDA approves updated COVID-19 shots but limits access for some kids and adultsU.S. regulators have approved updated COVID-19 shots from Pfizer, Moderna, and Novavax, but access is now limited for younger adults and ch...
CVS removes popular cough and cold medicines from store shelvesCVS has removed popular oral cough and cold medicines like Sudafed, Mucinex, Vicks, Allegra, and Dayquil from its stores. The FDA advisory ...
Popular nasal decongestant Sudafed, Allegra, and Dayquil doesn't actually relieve congestionFDA advisers unanimously vote against phenylephrine's effectiveness in over-the-counter decongestants. Recent studies suggest it provides n...
US proposes once-a-year Covid shots for most AmericansThe proposal comes as boosters have become a hard sell. While more than 80% of the U.S. population has had at least one vaccine dose, only ...
U.S. FDA reviews Pfizer & Moderna Covid 19 vaccines in young childrenUS health experts' panel will be reviewing the use of covid vaccines in young children on Wednesday. If the committee recommends using covi...
US FDA advisers to discuss second COVID vaccine boosters in AprilThe panel will also discuss the process for selecting COVID-19 vaccine strain to address current and emerging variants, the U.S. FDA said.
SEC to review companies' applications for Molnupiravir on MondayThe drug is touted as a game-changer in the fight against the pandemic, and a panel of experts of the US Food and Drug Administration (FDA)...
Final US hurdle for Merck's COVID-19 pill: FDA panel reviewIf authorized, Merck's pill would be the first that U.S. patients could take at home to ease symptoms and speed recovery, a major step towa...
U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in childrenThe age group is "far from being spared from the harm of COVID-19," with the virus now one of the top 10 causes of deaths in American child...
Key data on US J&J, Moderna COVID-19 boosters 'weeks away,' Fauci saysU.S. health regulators already have begun to consider a third dose of the Pfizer/BioNTech vaccine.
US panel recommends Covid boosters for people 65 and olderThe decisions came after a day-long meeting full of data presentations and at times charged debate that was convened by the Food and Drug A...
White House says U.S. can roll out COVID boosters next weekWhile some health officials, other countries and vaccine makers say boosters are needed, many experts disagree, including two top scientist...
Johnson & Johnson’s one-shot vaccine effective, safe: FDA staffJohnson & Johnson’s one-shot Covid-19 vaccine appeared safe and effective in trials, US Food and Drug Administration (FDA) staff said in do...
Moderna's COVID-19 vaccine clears first US FDA hurdleFDA staff said a two-dose regimen of Moderna's vaccine was highly effective in preventing confirmed cases of COVID-19. The comments were ma...
Pfizer COVID-19 vaccine faces last hurdle before US decisionThursday's meeting of the Food and Drug Administration's vaccine advisory panel is likely the last step before a U.S. decision to begin shi...
Moderna expects emergency nod soon after FDA panel meet: CEOThe Food and Drug Administration is scheduled to hold the meeting on Dec. 17 to discuss the company’s request for emergency use authorisati...
Trump to meet COVID-19 vaccine makers, distributors next week: Stat NewsThe meeting would take place days ahead of reviews of vaccine candidates from Moderna Inc and Pfizer-BioNTech SE Inc by two separate panels...
FDA panel reviews first new Alzheimer's drug in 2 decadesA panel of outside experts meets Friday to advise the Food and Drug Administration on aducanumab, a drug from Cambridge, Massachusetts-base...
USFDA issues warning letter to Wockhardt's UK facilityThe significant violations included non-adherence to appropriate written procedures that are designed to prevent contamination of drugs.
- Experts urge US to restrict drug Avandia
A majority of members of a key advisory committee recommended Wednesday that the US government allow diabetes drug Avandia to stay on the m...