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The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...
1don MSN
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
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 ...
Genetic testing could not confirm Duchenne muscular dystrophy, but a muscle biopsy at UCLA did. "He could see that he was ...
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
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