The FDA had asked Sarepta to voluntarily halt all shipments of Elevidys following the deaths of three nonambulatory Duchenne ...

The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

Sarepta Therapeutics shares jumped over 36% in premarket trading on Tuesday after the company said it had received US Food ...

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...