TAR-200, a gemcitabine-releasing system, received FDA priority review for high-risk non-muscle invasive bladder cancer unresponsive to BCG. Phase 2b SunRISe-1 trial data showed an 82.4% complete ...
FDA Priority Review targets perioperative enfortumab vedotin plus pembrolizumab use in MIBC irrespective of cisplatin eligibility, with an August 17, 2026 decision date. EV-304/KEYNOTE-B15 showed a 47 ...