News

Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
The ask comes days after Sarepta, which has a major presence in Columbus, announced it would lay off 500 workers, including 80 in central Ohio. The Food and Drug Administration announced ...
STAT5y
The FDA and Sarepta: A window into the world of drug regulation | STAT
The FDA's decisons about Exondys 51 and Vyondys 53, both developed by Sarepta Therapeutics, offer a rare glimpse into the world of drug regulation. Skip to Main Content FDA ...
FierceBiotech2y
In a U-turn, FDA orders AdComm for Sarepta's DMD gene therapy
At the end of last month, Sarepta told investors it had completed the midcycle review for the SRP-9001 submission, and, with no significant safety or clinical issues coming up, the FDA had ...
Yahoo8y
FDA approves Sarepta’s controversial drug for Duchenne ... - Yahoo
The US Food and Drug Administration approved a Sarepta drug to treat Duchenne muscular dystrophy that it had rejected in April as ineffective.
Reuters2y
FDA reviewers raise doubts over data on Sarepta's gene therapy
The U.S. Food and Drug Administration's staff reviewers raised concerns over limited data on Sarepta Therapeutics Inc's gene therapy for a muscle-wasting disorder, ahead of a meeting of the agency ...
MarketWatch5y
Sarepta stock falls on FDA concerns about drug - MarketWatch
Sarepta Therapeutics Inc. shares fell in the extended session Monday after the drug maker said the Food and Drug Administration raised concerns about its muscular dystrophy treatment. Sarepta ...
Benzinga.com2y
FDA Staff Raises Issues For Sarepta's Duchenne Gene Therapy Data ...
The FDA's Cellular, Tissue and Gene Therapies Advisory Committee is meeting this Friday to discuss Sarepta Therapeutics Inc's (NASDAQ: SRPT) to review SRP-9001 (delandistrogene moxeparvovec ...
Becker's Hospital Review8y
FDA approves Sarepta’s controversial muscular dystrophy drug
Cambridge, Mass.-based Sarepta Therapeutics earned tentative approval from the Food and Drug Administration for its Duchenne's muscular dystrophy drug eteplirsen, according to The New York Times ...
Wall Street Journal9y
Sarepta: FDA’s Decision on Dystrophy Drug Delayed - WSJ
Sarepta Therapeutics Inc.SRPT-3.03%decrease; red down pointing triangle said the U.S. Food & Drug Administration wouldn’t issue a decision on the company’s muscular dystrophy drug by Thursday ...
Las Vegas Sun2d
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators ...