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

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 said on Monday it is recommending the removal of the hold placed on Sarepta ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

Sarepta will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug Administration ...

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...

FDA recommends lifting the hold on Sarepta's gene therapy Elevidys for ambulatory patients after investigation; ...

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...

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

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

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