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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 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 ...
Exclusive: 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
Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to 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 ...
BioSpace1d
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 ...
pharmaphorum6d
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
Multiple studies of Sarepta's DMD therapy halted after death
The EMA has called a temporary halt to a phase 2 trial of Sarepta's Roche-partnered Duchenne muscular dystrophy (DMD) gene therapy Elevidys in the wake of the death of a patient who received the ...