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 ...

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 ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy. The company's stock has been under pressure for ...

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

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

The FDA is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics to treat Duchenne muscular dystrophy. The child died June 7, prompting ...

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...

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 ...

Sarepta Therapeutics now trades at book value with strong cash and cost-cutting plans, while ELEVIDYS may regain broader use.