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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 ...
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.
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 ...
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 ...
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 ...
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 ...
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 ...
Health and Me on MSN2h
"Obsolete And Unnecessary": FDA Set To Revoke 52 Nutrition And Labeling Rules
The FDA plans to revoke 52 outdated nutrition and labeling regulations to streamline food industry standards, citing them as ...
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 ...
STAT12d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
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 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 ...