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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 ...
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 MSN2d
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 ...
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 ...
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 ...
Agence France-Presse on MSN2d
US may revise hormone replacement therapy warnings
US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels ...
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The FDA May Finally Remove The Black Box Warning On Hormone Therapy Products. Here’s When It Might Happen
Hormone therapy has endured a rather bumpy history after the Women’s Health Initiative published clinical trial data in 2002 ...
Asianet Newsable on MSN1d
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 ...
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 ...
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 ...
RFK Jr. and other Trump officials embrace psychedelics after FDA setback
For decades, proponents of psychedelic drugs have come to Washington with a provocative message: Illegal, mind-altering ...
Live coverage: FDA’s Makary talks animal testing phase-out at Hill Nation Summit
Nearly six months into President Trump’s second term, The Hill and NewsNation team up to host the inaugural Hill Nation ...