29 May 2024 - Target action (PDUFA) date set for 29 November 2024.
Jazz Pharmaceuticals today announced that the US FDA has accepted and granted priority review of the biologics license application for zanidatamab, the human epidermal growth factor receptor 2 (HER2) targeted bispecific antibody, for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2 positive biliary tract cancer.