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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 ...
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's Setback Deepens With Another Gene Therapy Fatality
Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene ...
BioSpace1 天
Sarepta Reports a Third Gene-Therapy Related Patient Death
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute ...
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 shares plunge 40% as future of its gene therapy appears at risk
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk.
BioPharma Dive17 小时
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 ...
STAT1 天
Patient dies in Sarepta gene therapy trial, adding to safety concerns
A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...
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 ...
Devdiscourse4 小时
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 ...
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 ...
Exclusive-US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...