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

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

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

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

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

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

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

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

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

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