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Merck & Co., Inc. (MRK) Gains FDA Priority Review for KEYTRUDA Regimen in Muscle-Invasive Bladder Cancer
Merck & Co., Inc. (MRK) has received FDA Priority Review for its KEYTRUDA and KEYTRUDA QLEX regimen when used in combination with Padcev for muscle-invasive bladder cancer patients eligible for cisplatin-based chemotherapy. The FDA set an August 17, 2026 target action date, with the applications supported by positive Phase 3 KEYNOTE-B15 data showing improved outcomes and survival benefits. This news follows Merck’s recent announcement of a tender offer to acquire Terns Pharmaceuticals for $53.00 per share, expected to close in the second quarter of 2026.