stem cells
Federal Appeals Court Rules Against Stem Cell Clinic, Affirms Autologous Cell Therapies Are 'Drugs'
The decision reaffirming the FDA's oversight authority over cell and gene therapy products was praised by the International Society for Cell & Gene Therapy.
BrainStorm Cell Therapeutics to Launch NurOwn Phase IIIb Trial This Year With FDA Feedback
The firm has received the agency's feedback through a special protocol assessment on a study design that may yield registrational data.
BrainStorm Cell Therapeutics 'Committed' to NurOwn Despite Setbacks, Says Success in ALS 'Critical'
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The company is waiting for the FDA to weigh in on a Phase IIIb study design and is exploring multiple options for raising needed capital.
BrainStorm Cell Therapeutics Pushes Ahead With NurOwn in ALS, Requests FDA Feedback on New Trial
The company last year withdrew its BLA for the experimental stem cell therapy after an FDA advisory committee found the submitted data lacking.
BrainStorm Cell Therapeutics Reducing Headcount by 30 Percent to Fund Phase III NurOwn Trial
The biotech firm said it planned to reduce resource consumption by 50 percent and is looking for ways to raise more capital.
Sep 28, 2023