Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

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

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...

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

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

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...

The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

The Food and Drug Administration is investigating Sarepta’s gene therapy products following reports of a third death from acute liver failure.

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...