Posted by Michael Wonder on 06 Nov 2024
Merus receives FDA extension of PDUFA for zenocutuzumab
5 November 2024 - Merus today announced that the US FDA has extended the PDUFA goal date for zenocutuzumab biologics license application currently under priority review.
The US FDA has extended the PDUFA goal date to 4 February 2025 to enable sufficient time to review information recently submitted by the Company in response to a CMC information request. No additional clinical data have been requested.
