Keeping Track: Another Gene Therapy Approval, Several Priority Review Designations, And Many Resubmissions
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Spark's Early Christmas Present: US FDA Approves Luxturna For Vision Loss
Review and approval of first directly administered gene therapy targeting a disease caused by genetic mutations embodies 'spirit' of agency's forthcoming series of guidance documents on gene therapies, FDA Commissioner Gottlieb says; documents are likely to encourage development of the kind of novel and clinically meaningful endpoint that Spark used in its clinical program.