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Sarepta continues Duchenne drug shipments amid FDA safety concerns and investigation.
Sarepta Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Elevidys, despite a request from the FDA to halt shipments following three patient deaths linked to gene therapy technology.
Sarepta refuses to pause deliveries to ambulatory patients, stating that data shows no new safety signals for this group.
The FDA is investigating the risk of acute liver failure linked to Sarepta's platform.
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Sarepta continúa con los envíos de fármacos Duchenne en medio de las preocupaciones de seguridad de la FDA y la investigación.