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

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 ...

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

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

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) ...

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 ...

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

Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...

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

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