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 Monday it is recommending the removal of the hold placed on Sarepta ...

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

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

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

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 ...

Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...

The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ...

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

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 ...

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