FDA Advisory Committee meeting to review NurOwn BLA scheduled for September 27, 2023.- BrainStorm Cell Therapeutics
BrainStorm Cell Therapeutics Inc. a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that the FDA will convene a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (ADCOM) to review the Biologics License Application (BLA) for NurOwn, its investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS)
The advisory committee meeting has been scheduled for September 27, 2023, and will be available for live streaming. In addition, BrainStorm's BLA for NurOwn has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023.
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