Latest News - Spark Therapeutics

Monday, July 31, 2017 | Clinical Trials, Retina, Spark Therapeutics

Spark Therapeutics Submits Marketing Authorization Application to European Medicines Agency for Investigational Luxturna (Voretigene Neparvovec)

Spark Therapeutics announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Luxturna, the proposed trade name for voretigene nep…

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Thursday, July 20, 2017 | Retina, Spark Therapeutics

Spark Therapeutics Receives Rare Pediatric Disease Designation for Investigational Luxturna (Voretigene Neparvovec) from FDA

Spark Therapeutics announced that the Offices of Orphan Products Development and Pediatric Therapeutics of the FDA have designated investigational Luxturna (voretigene neparvovec) as a drug …

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Monday, July 17, 2017 | Clinical Trials, Spark Therapeutics

Spark Therapeutics’ Biologics License Application for Investigational Voretigene Neparvovec Accepted for Filing by FDA

Spark Therapeutics announced that the FDA has accepted for filing the biologics license application (BLA) and granted priority review for voretigene neparvovec, an investigational, potential one-time …

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