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The FDA’s briefing documents found that the BrainStorm BLA submission for its investigational cell therapy did not demonstrate evidence of effectiveness and that the manufacturing data was “grossly deficient.”
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
By Chris Wack BrainStorm Cell Therapeutics Inc. said Monday that the U.S. Food and Drug Administration will hold an Advisory Committee Meeting to discuss the company's Biologics License... | March 27, 2023
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today...
BrainStorm Cell Therapeutics Inc. (BCLI) announced the FDA will hold an Advisory Committee Meeting to discuss the company's Biologics License Application for NurOwn for the treatment of amyotrophic lateral sclerosis.