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The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute ...
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.
Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...
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