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FDA recommended generating additional clinical data to meet FDA’s BLA requirements NEW YORK – BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it recently met with senior leadership from the U.S. Food and Drug Administration (FDA) and received...
NEW YORK and SOMERSET, N.J. – BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, and Catalent (NYSE: CTLT), a global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that...
NEW YORK, NY — Brainstorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today provided an update on the grant and allowance of three patent applications for NurOwn® and NurOwn-Exosomes. The European Patent office granted patent No. 3105587 titled ‘Method of Qualifying of Cells’...
NEW YORK, NY — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn®, its investigational...
Biomarker data suggest that NurOwn drives significant changes on multiple biomarkers across ALS disease pathways which may be important in achieving clinical outcomes NEW YORK – BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that biomarker data on NurOwn® will be...
A brave baby who recently had both kidneys removed was left fighting for life after developing a serious chest infection. Twenty-month-old Ella Chadwick underwent the radical surgery in April as her only hope of survival against the rare Congenital Nephrotic Syndrome, a potentially fatal disorder that affects one in 10,000...