News

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request
The FDA called for Sarepta Therapeutics to stop shipping its muscular dystrophy gene therapy, but the company said no.
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Sarepta Tells FDA It Won’t Stop Shipments Despite Patient Deaths
Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...
Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...
Devdiscourse13h
Sarepta Defies FDA Order Amidst Gene Therapy Controversies
Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...
Sarepta tells FDA it won’t halt shipments despite patient deaths
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...
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Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
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FDA Wants Elevidys Off the Market. Sarepta Said No.
Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
Sarepta to continue Elevidys shipments despite FDA request to halt
Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
MedPage Today24d
FDA Probes Gene Therapy After Two Deaths - Medpage Today
The FDA is investigating the deaths of two boys with Duchenne muscular dystrophy who died soon after being treated with delandistrogene moxeparvovec (Elevidys) gene therapy, the agency said.
WREG1mon
Second patient death reported with gene therapy for muscular dystrophy
Elevidys is the first gene therapy approved in the U.S. for the rare muscle-wasting condition, but it has faced scrutiny since its accelerated approval in 2023.