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The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...
2hon MSN
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
US regulators said they are investigating the death of an 8-year-old boy who received a gene therapy from Sarepta ...
European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...
Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU
EMA’s CHMP issued an opinion not to recommend Elevidys™ (delandistrogene moxeparvovec) for the treatment of ambulatory ...
Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...
Genetic testing could not confirm Duchenne muscular dystrophy, but a muscle biopsy at UCLA did. "He could see that he was ...
When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...
The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
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