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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 September 27, 2023, to discuss and make recommendations on biologics license application (BLA) 125782 from BrainStorm Therapeutics, Inc. for debamestrocel NurOwn® (autologous bone marrow-derived mesenchymal stromal cells induced to secrete neurotrophic factors (MSC-NTF). BrainStorm Therapeutics has requested an indication for the treatment of amyotrophic lateral sclerosis (ALS).

Source:: https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-public-participation-information-september-21-2023-meeting-endocrinologic-and-metabolic#event-materials
Earlier Event: September 21
Endocrinologic Drugs Advisory Committee
Later Event: October 4
Oncologic Drugs Advisory Committee