Sarepta FDA Compliance Issues

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FDA, Sarepta Therapeutics

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

Sarepta Therapeutics shares traded lower in premarket trade on Tuesday, as the drugmaker relented to a Food and Drug Administration request to halt the shipments of a gene therapy.

The Columbus Dispatch on MSN · 17h

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 the move,

STAT · 16h

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

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 ...

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 ...

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

Sarepta says FDA may limit gene therapy nod to smaller population ...

Sarepta says FDA may limit gene therapy nod to smaller population, shares fall. By Leroy Leo and Aditya Samal. May 24, 2023 2:59 PM UTC Updated May 24, 2023 Signage is seen ...

STAT8y

FDA emails show how upset some officials were over Sarepta approval

FDA emails show how upset some officials were over the Sarepta approval. By Ed Silverman Nov. 4, 2016. ... The details of that dispute were released at the time the FDA approved the Sarepta ...

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 ...

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 ...

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 Journal8y

FDA Approves Sarepta’s Muscular Dystrophy Drug - WSJ

The U.S. Food and Drug Administration on Monday gave accelerated approval to the first drug for the crippling disease Duchenne muscular dystrophy, from Sarepta Therapeutics Inc., after sharp ...

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