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Sarepta resists as FDA seeks pause on Elevidys use
Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...
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 ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta ...
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request
When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...
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 ...
BioPharma Dive2d
FDA to ask Sarepta to stop shipping Duchenne gene therapy
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
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 ...
Southwest Journal2d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
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 ...