After Lung Cancer Approval, AstraZeneca's Imfinzi Goes Under FDA Priority Review For Bladder Cancer

On Friday, the FDA accepted and granted Priority Review AstraZeneca Plc's (NASDAQ:AZN) supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for patients with muscle-invasive bladder cancer (MIBC).

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the second quarter of 2025.