Posted by Michael Wonder on 16 Apr 2024
GSK’s 5 in 1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met.
GSK today announced that the US FDA has accepted for review a biologics license application for its 5 in 1 meningococcal ABCWY vaccine candidate. The PDUFA action date for a regulatory decision by the US FDA on this application is 14 February 2025.
