Children's Hospital LA Pauses Use of Sarepta Gene Therapy
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Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical hold request from the FDA.
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SRPT Down After Third Death in Muscular Dystrophy Gene Therapy ProgramSarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.
A Massachusetts biotechnology company is laying off 21 employees in Durham amid a broader restructuring and pressure from federal regulators.
FDA may face scrutiny This latest incident casts a shadow over Elevidys, Sarepta’s flagship therapy, and may increase scrutiny of the U.S. Food and Drug Administration’s decision to approve ...
On Wednesday, HC Wainwright reiterated its Sell rating for Sarepta, maintaining a price forecast of $10.Analyst Mitchell Kapoor stated his belief that “it is highly likely that the FDA will at ...
On the 10-meter distance test, the drug was associated with a 0.42-second improvement versus placebo, Sarepta said. Related Most expensive drugs in the US in 2023
Sarepta says more than 800 patients have received the treatment The company plans to update prescribing information after this case WEDNESDAY, March 19, 2025 (HealthDay News) -- A patient has died ...
The FDA's decisons about Exondys 51 and Vyondys 53, both developed by Sarepta Therapeutics, offer a rare glimpse into the world of drug regulation. Skip to Main Content FDA
Rather, Sarepta’s understanding is that the U-turn results from a reorganization at the FDA, the creation of the “super office” OTP—the Office of Therapeutic Products—and a desire to ...
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