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Orchard Therapeutics: FDA Acceptance of BLA Application for Product OTL-200 for the Treatment of Metachromatic Leukodystrophy

Orchard Therapeutics: FDA Acceptance of BLA Application for Product OTL-200 for the Treatment of Metachromatic Leukodystrophy

Today’s Highlights September 18, 2023

Orchard Therapeutics in the NEWS
Today, September 18, 2023, Orchard Therapeutics (ORTX) - a global gene therapy firm, announced that the U.S. 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.
From Orchard Therapeutics
Bobby Gaspar, M.D., Ph.D., co-founder and chief . . .

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Today’s Highlights
September 18, 2023

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