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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.
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...
The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved ...
The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...
European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
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