PTC Therapeutics, Inc. announced that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency. The application has been granted Priority Review with a target regulatory action date of November 13, 2024.
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- PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza