The company said in a statement that the FDA notified it on Monday and plans to resume shipping Elevidys to sites of care for treatment of ambulatory patients with Duchenne “imminently. “ The FDA ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Just before 6:00 p.m. ET ...

New York, June 22, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) accelerated approval of ELEVIDYS (delandistrogene moxeparvovec ...

Wedbush has initiated Sarepta Therapeutics (SRPT) at outperform saying that a selloff that began earlier this year following ...

Sarepta Therapeutics, Inc. (SRPT) on Tuesday said that the U.S. Food and Drug Administration (FDA) has approved dosing in a study cohort to evaluate the use of an immunosuppressive regimen as part of ...

- Sarepta and FDA will continue dialogue on next steps in the safety labeling process and risk-mitigation approach for non-ambulatory patients Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in ...

CHMP issued a negative opinion on Elevidys for Duchenne patients aged 3–7 despite secondary gains in motor function. Elevidys has treated over 900 DMD patients, but EMA and FDA raise concerns over ...

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics (NASDAQ:SRPT) gene therapy for Duchenne ...

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...

On November 25, 2025, Sarepta Therapeutics filed two petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to ...

- Sarepta and FDA will continue dialogue on next steps in the safety labeling process and risk-mitigation approach for non-ambulatory patients Sarepta will resume shipping ELEVIDYS to sites of care ...