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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 ...
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 Today on MSN17h
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 ...
News Nation on MSN1d
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 ...
Agence France-Presse on MSN1d
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 ...
Asianet Newsable on MSN20h
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 ...
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 ...
BioSpace3d
FDA Commissioner Marty Makary Proposes Lowering Industry User Fees
According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
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 ...
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 ...
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 ...