Shortly after the U.S. FDA announced an investigation into the death of a patient who had received Elevidys, a gene therapy ...

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the ...

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday, down more than 4% in pre-market trade, following a rough end to ...

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne ...

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...