News

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 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 ...
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 ...
MedPage Today6h
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 ...
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 ...
Axios on MSN17h
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 ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
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 ...
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 ...