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 […]
FDA Flags Potential Guillain-Barre Risk With RSV Vaccine Candidates
Ahead of a 2-day meeting with FDA’s vaccine advisors, reviewers at the agency highlighted a rare but potential risk for Guillain-Barré syndrome with two vaccine candidates for respiratory syncytial virus (RSV). On Tuesday and Wednesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will recommend whether the risk-benefit profile with Pfizer and GSK’s vaccine […]