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

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...
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 ...
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 ...
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 ...
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 ...