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FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to Bloomberg News that linked the probe to a fatality in Brazil and held that the death of the patient was unrelated to Elevidys itself.
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
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FDA Official Who Halted Sarepta’s Gene Therapy Resigns Amid Backlash Over Access To Duchenne TreatmentVinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
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