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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 ...
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 ...
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.
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Duchenne Gene Therapy Will Undergo Changes After Patient Deaths
At the FDA's request, delandistrogene moxeparvovec (Elevidys), the only approved gene therapy for Duchenne muscular dystrophy ...
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 ...
Patient dies in Sarepta gene therapy trial, adding to safety concerns
The death will likely further stoke safety concerns around Sarepta's gene therapies, as well as raise questions around the ...
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BioSpace9h
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 ...
Patient Deaths Linked to Sarepta Gene Therapy Prompt FDA Probe
The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta ...
Southwest Journal10h
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
BioPharma Dive7h
Patient reportedly dies in Sarepta study of limb-girdle gene therapy
According to multiple reports, a 51-year-old man with limb-girdle muscular dystrophy died from acute liver failure after ...
Managed Healthcare Executive2h
Gene Therapy for Inherited Macular Degeneration Begins Pivotal Trial
In early research, OCU410ST, a gene therapy for Stargardt disease, demonstrated slowed lesion growth by 48% at the 12-month follow-up in evaluable treated eyes.