Spark Therapeutics’ and Novartis Luxturna gene therapy for a rare inherited eye disease has been okayed by European regulators, paving the way for an EU licence in the coming months. A marketing ...

Last month an FDA advisory committee voted unanimously in favour of approval for voretigene neparvovec (to be named Luxturna) for patients with confirmed biallelic RPE-mediated inherited retinal ...

A drug that receives Fast Track designation may benefit from more frequent interactions with the FDA throughout drug development. In addition, the Fast Track program allows for Accelerated Approval ...

Phacilitate, a leading brand that connects advanced therapies industry leaders through inspiring conferences, vibrant communities and market intelligence, today presented Katherine A. High, M.D. with ...