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FDA accepts biologics license application for voretigene neparvovec
The FDA has accepted a biologics license application and granted priority review for voretigene neparvovec, according to a press release from Spark Therapeutics.An investigational gene therapy candidate for vision loss due to biallelic RPE65-mediated inherited retinal disease (IRD), voretigene neparvovec, which has the proposed trade name of Luxturna, could be both the first gene therapy for a genetic disease in the United States and the first pharmacologic treatment for IRD, the release said.