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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 ...
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 ...
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 ...
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 ...
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.
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 ...
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 ...
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 ...
Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...