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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 ...
MedPage Today3h
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 ...
F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments
Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...
Asianet Newsable on MSN6h
FDA Is Reportedly ‘Taking A Hard Look’ To Evaluate Whether Sarepta’s Gene Therapy Elevidys Should Remain On The Market
The growing number of fatalities is raising questions about the future of Sarepta’s therapies and the regulatory path for ...
News Nation on MSN22h
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 ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics to voluntarily stop all shipments of its ...
Sarepta plunges as FDA is reportedly evaluating if gene therapy should remain on market
Sarepta Therapeutics (NASDAQ:SRPT) shares dropped to a new 52-week low on Friday, triggering a trading halt after Bloomberg ...
Gene-therapy company to eliminate 21 Durham employees as part of major restructuring
Sarepta Therapeutics, which this week announced plans to restructure amid regulator concerns over at least one of its ...
STAT4dOpinion
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 ...
MedPage Today on MSN1d
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 ...
Sarepta shares plunge 30% as future of its gene therapy appears at risk
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its key gene therapy treatment appeared at risk. The Food and Drug Administration will request that the company ...