US FDA recommends removal of hold on Sarepta's Elevidys in some patients
ReutersJul 28, 2025 8:56 PM
July 28 (Reuters) - The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta Therapeutics' SRPT.O gene therapy Elevidys for patients with a rare muscular disorder who can walk.
The FDA's recommendation followed a probe that showed the death of an 8 year old boy was unrelated to the gene therapy for Duchenne Muscular Dystrophy, the agency said.
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