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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 man who received a similar product in a clinical trial for a different form of muscular dystrophy.
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 muscular dystrophy patient who received a different, experimental treatment died,
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...
MedPage Today on MSN2d
Duchenne Gene Therapy Will Undergo Changes After Patient DeathsAt the FDA's request, delandistrogene moxeparvovec (Elevidys), the only approved gene therapy for Duchenne muscular dystrophy ...
Shares of Sarepta Therapeutics (NASDAQ: SRPT) plunged 26.85% in Friday pre-market after a clinical trial participant died ...
Sarepta Therapeutics to lay off 493 workers, including 80 in Ohio, amid FDA probe, stock plunge, and concerns over Duchenne ...
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...
Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Elevidys, or a similar ...
The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after ...
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