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FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market
US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...
Axios on MSN1d
FDA panel backs menopausal hormone therapy
An Food and Drug Administration expert panel on Thursday endorsed removing the "black box" warning on hormone treatments for ...
Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request
The FDA called for Sarepta Therapeutics to stop shipping its muscular dystrophy gene therapy, but the company said no.
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...
STAT5dOpinion
The FDA commissioner is a gifted talker — but the job is about more than that
FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...
News Nation on MSN2d
FDA chief: HRT warning among ‘greatest mistakes of modern medicine’
( NewsNation) — The head of the U.S. Food and Drug Administration signaled Thursday that he supports changing or removing the ...
MedPage Today on MSN3d
A 'Culture Change' Is Needed in Academic Medicine, FDA Commissioner Says
The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The ...
MedPage Today on MSN1d
Remove Boxed Warning on Hormone Therapy for Menopause, FDA Panel Says
A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...
FDA Commissioner Marty Makary Says The FDA Is 'Now Revising' Saturated Fat Guidelines
During a press conference on Monday, Food and Drug Administration Commissioner Marty Makary spoke about the agency's ...
RFK Jr. and other Trump officials embrace psychedelics after FDA setback
Health Secretary Robert F. Kennedy Jr. and other Trump officials are signaling their interest in approving psychedelic drugs ...
Stocktwits on MSN1d
FDA Is Reportedly ‘Taking A Hard Look’ To Evaluate Whether Sarepta’s Gene Therapy Elevidys Should Remain On The Market
US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether Sarepta Therapeutics’ gene therapy, Elevidys, should remain on the market, following recent patient ...
Sarepta tells FDA it won’t halt shipments despite patient deaths
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...