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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 30% 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.
MedPage Today on MSN22h
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 ...
US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
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 ...
BioSpace5h
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 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 ...
Gene therapy developer Sarepta faces third patient death
Investors showed growing mistrust of the Sarepta team, repeatedly asking why the Cambridge company had not disclosed the ...
Southwest Journal7h
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 Dive4h
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 ...
FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market
US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...
pharmaphorum6h
Third death reported with a Sarepta gene therapy
A third fatality has been recorded among patients receiving treatment with a Sarepta gene therapy, adding to the troubles ...