The FDA granted fast track designation to SBE303, Samsung Bioepis’ investigational Nectin-4–targeting ADC, for advanced urothelial cancer following enfortumab vedotin.
FDA expands nogapendekin alfa inbakicept plus BCG use to high-grade papillary-only BCG-unresponsive NMIBC, offering durable control and strong cystectomy-avoidance outcomes.