FDA Advisory Panel Unanimously Recommends Approval of Spark Therapeutics' Gene Therapy Luxturna
Spark Therapeutics is on track to win FDA approval later this year to market the first gene therapy ever authorized to treat an inherited disease in the U.S., following an advisory committee’s unanimous recommendation yesterday in favor of the company’s Luxturna™ (voretigene neparvovec).The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 16-0 to recommend approval of Spark’s lead candidate Luxturna, after concluding that the gene therapy’s
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