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FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.
European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...
FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ...
CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy: Basel Monday, July 28, 2025, 15:00 Hrs [I ...
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 ...
Genetic testing could not confirm Duchenne muscular dystrophy, but a muscle biopsy at UCLA did. "He could see that he was ...
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