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US FDA accepts first biologics license application for AstraZeneca’s durvalumab in bladder cancer
9 December 2016
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017.
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