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News 2026-09-25 11:00 UTC

AstraZeneca (AZN) Wins FDA Priority Review for Imfinzi+EV in MIBC

AstraZeneca’s sBLA for Imfinzi plus enfortumab vedotin in cisplatin-ineligible or -declining muscle-invasive bladder cancer received FDA Priority Review, with a PDUFA action date anticipated in Q4 2026.Material DetailsContext by AI AnalystThis is a mid-cycle regulatory milestone building on prior p…