The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...

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

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

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 gene therapy Elevidys to patients with a rare muscular ...

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

Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...

The manufacturing-related rejection also delays a key test of the new FDA leadership’s support for cell and gene therapy against rare diseases.

The FDA published a database containing more than 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products, The New York Times reported July 10 ...