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 ...

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

The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, ...

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 ...

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

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...

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

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

Towards the end of June, Sarepta Therapeutics started facing a temporary suspension of shipments for ELEVIDYS, which is its gene therapy for Duchenne muscular dystrophy/DMD, specifically for non ...

Sarepta led investors to believe that its ELEVIDYS therapy was both safe and had potential for approval in wider applications. The Company misled the market about its revenue outlook on ELEVIDYS.