News

A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...
The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...
Health Secretary Robert F. Kennedy Jr. and other Trump officials are signaling their interest in approving psychedelic drugs ...
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...
Shares of Sarepta Therapeutics (NASDAQ:SRPT) continued to fall on Friday as Reuters reported that the U.S. FDA plans to ...
The growing number of fatalities is raising questions about the future of Sarepta’s therapies and the regulatory path for ...
A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...