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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 Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
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 ...
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 ...
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 ...
BioSpace2d
Sarepta Craters as FDA Considers Requesting Halt to Elevidys Shipments
The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a ...
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 request Sarepta Therapeutics to voluntarily stop all shipments of its ...
pharmaphorum1d
DMD gene therapy Elevidys linked to new liver failure case
Sarepta Therapeutics and partner Roche have reported a second case of fatal liver failure with their Duchenne muscular dystrophy (DMD) gene therapy Elevidys and stopped using it to treat some ...
pharmaphorum2d
Sarepta slumps on Elevidys patient death | pharmaphorum
The death of a patient treated with Sarepta's Duchenne muscular dystrophy (DMD) gene therapy Elevidys has played havoc with its share price – although analysts believe that its benefits still ...