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The approval follows the December 2024 priority review designation for this perioperative immunotherapy regimen for patients fighting muscle-invasive bladder cancer.

Approval was based on improved survival outcomes vs platinum-based chemotherapy as demonstrated in the phase 3 NIAGARA study.

(AP Photo/John Bazemore, File)(AP/John Bazemore) TORONTO (AP) — Washington Nationals right-hander Michael Soroka left ...

FDA approved AstraZeneca's Imfinzi regimen for muscle-invasive bladder cancer, while the EU backed Calquence combo for untreated mantle cell lymphoma.