Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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FDA Panel Agrees GSK’s RSV Vaccine Is Effective But Wants More Data Before Approval
Advisory committee votes 10-2 that data are adequate to support safety of the vaccine in adults 60 and older, voicing concern about small potential safety signals after co-administration with influenza shot. Several members question rush to market with just one season of data.
Pfizer’s RSV Vaccine: Two Positive Votes Don’t Necessarily Add Up To AdComm Endorsement
Pfizer got positive standalone votes on safety and efficacy for its RSV vaccine in older adults at a US FDA advisory committee, but only three advisors – a minority of the 12-member panel – endorsed both the safety and effectiveness of the firm’s candidate.
Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.