News

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second ...
Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and ...
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
Sarepta Therapeutics faces challenges as the FDA halts gene therapy trials for LGMD and revokes AAVrh74 platform designation.
Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...
Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was ...
Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...
Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments ...
Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...