News

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
FDA to ask Sarepta to stop shipping Duchenne gene therapy
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
WCMH Columbus on MSN2d
Sarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in Columbus
Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location.
MedPage Today14m
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...
Southwest Journal3d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
The Pharma Letter2d
FDA investigating deaths linked to Sarepta’s AAVrh74 gene therapies
As of July 18, 2025, the Food and Drug Administration (FDA) said it has received three reports of fatal acute liver failure ...
Cambridge pharma company lays off almost 500 amid FDA dispute over treatment
A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
BioPharma Dive23m
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...