Pfizer’s RSV Vaccine: US FDA Panel Wants Robust Safety Program With Public Accountability
Advisory committee offers strong support for approval of Pfizer’s RSV vaccine to protect infants while simultaneously offering the agency a handful of suggestions that were directed towards the review and post-market surveillance of all vaccinations.
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Everything’s Coming Up Pfizer: The Biggest Of Pharma Firms Leads Industry In Pending Applications For US FDA Approval
Pfizer’s lineup of novel agents under review stands at seven, while no other big pharma has more than two novel candidates; Sanofi is tops in recent approvals since 2021, with seven novel agents cleared, but has no pending NMEs.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Pfizer’s Maternal RSV Vaccine Quest May Hinge On FDA Advisors’ Views of Preterm Birth Data
A numerical – but not statistically significant – imbalance in preterm births was seen in two Pfizer studies of its RSV vaccine when given to pregnant people with the aim of protecting newborns.