FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapy
FDA reviewers voiced serious concerns about the investigational amyotrophic lateral sclerosis (ALS) treatment debamestrocel — mesenchymal stromal cells secreting neurotrophic factors, also known as MSC-NTF, or NurOwn — from BrainStorm Cell Therapeutics ahead of an advisory committee meeting this week. When the FDA first received the drug’s application for approval, it determined the submission was […]