While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular ...

A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...

Shares of Sarepta Therapeutics fell close to 37% on Friday after reports emerged that the US Food and Drug Administration is considering whether to halt the distribution of Elevidys, the company’s ...

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.

The FDA has come up with a series of ... some added regulatory context on troublesome issues like the added threat of adverse ... before green-lighting the drug. But with Sarepta, ...

Any company that plans to mimic the approach taken by Sarepta Therapeutics to win regulatory approval of a drug should think twice. That was the blunt message delivered on Tuesday by a high ...

An FDA spokeswoman would not say when Farkas left, and whether his departure is tied to the review for the Sarepta drug is not known. Farkas could not be reached for comment. But he has played a ...

Sarepta Therapeutics, hoping to win approval with a treatment for Duchenne muscular dystrophy, will have to endure a three-month FDA delay before getting final word on its drug.

The US Food and Drug Administration approved a Sarepta drug to treat Duchenne muscular dystrophy that it had rejected in April as ineffective.