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FDA Accepts Orchard’s BLA for Rare Disease Gene Therapy Behind EU Approval

FDA Accepts Orchard’s BLA for Rare Disease Gene Therapy Behind EU Approval

19th September 2023

The FDA on Monday accepted Orchard Therapeutics’ Biologics License Application for OTL-200, an investigational gene therapy for rare disease metachromatic leukodystrophy that was approved in Europe in 2020. Source: Biospace 19/9/2023

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