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Devdiscourse4h
Scrutiny Intensified: FDA Calls Halt on Sarepta's Gene Therapy Amid Safety Concerns
The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but ...
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 ...
BioPharma Dive5h
Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...
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 ...
STAT7h
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
Gene-therapy company to eliminate 21 Durham employees as part of major restructuring
Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an ...
FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old ...
Devdiscourse8h
FDA Scrutiny Intensifies as Sarepta Gene Therapy Faces Dire Setbacks
The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...
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 ...
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Ele­vidys, or a similar ...
FDA Will Ask Sarepta to Halt Gene Therapy Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Sarepta shares fall 37% as FDA questions future of key gene therapy
Sarepta Therapeutics shares plunge over 37% as FDA weighs halting shipments of its key gene therapy, Elevidys, after patient ...