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

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

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

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...

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

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

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 has recommended lifting the voluntary hold on Sarepta Therapeutics (NASDAQ:SRPT)’ gene therapy Elevidys for ambulatory patients with Duchenne Muscular Dystrophy ...

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

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

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

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