Posted by Michael Wonder on 27 Jun 2023
FDA accepts Pfizer’s application for haemophilia B gene therapy fidanacogene elaparvovec
27 June 2023 - Submissions based on positive Phase 3 data from BENEGENE-2 trial.
Pfizer announced today that the US FDA has accepted the company’s biologics license application for fidanacogene elaparvovec for the treatment of adults with haemophilia B.
