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Cellular, Tissue, and Gene Therapies Advisory Committee

  • IQVIA Solutions Denmark A/S Denmark (map)

The USFDA has scheduled a Cellular, Tissue, and Gene Therapies Advisory Committee
[CTGTAC] on October 31, 2023, to discuss and make recommendations on biologics license application (BLA) 125787 from Vertex Pharmaceutical’s Inc. Exagamglogene autotemcel (exa-cel) for the treatment of Sickle cell disease (SCD) in patients 12 years and older with Recurrent Vaso-occlusive crises (VOCs).

Source:: https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-october-31-2023-meeting-announcement-10312023#event-materials
Earlier Event: October 5
Vaccines and Related Biological Products Advisory Committee
Later Event: November 16
Oncologic Drugs Advisory Committee