The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

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 ...

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 ...

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

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

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

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

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

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 ...

CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy: Basel Monday, July 28, 2025, 15:00 Hrs [I ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.