Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...

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 ...

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

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 ...