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

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

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

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

Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...

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

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

US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

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

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

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

The U.S. Food and Drug Administration has recommended lifting the voluntary hold on Sarepta Therapeutics (NASDAQ:SRPT)’ gene therapy Elevidys for ambulatory patients with Duchenne Muscular Dystrophy ...