Orchard Therapeutics Announced Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
Author: Charles Gross | September 18, 2023 07:37am
Orchard Therapeutics (NASDAQ:ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of March 18, 2024.
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