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FDA Approves First Gene Therapy to Treat Adults with Hemophilia B (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022)

On the 22nd of November 2022, FDA approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Please find more details of the announcement here.

See all of Catapult’s Regulatory Round-up for November 2022 here. Published on the 8th of December 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). FDA Approves First Gene Therapy to Treat Adults with Hemophilia B (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/o67p


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