The U.S. Food and Drug Administration approved UroGen’s bladder cancer hydrogel, Zusduri, intended for low-grade, intermediate-risk, non-muscle invasive bladder cancer. Approval comes despite a narrowly negative Oncologic Drugs Advisory Committee (ODAC) vote. The hydrogel is a non-surgical treatment option delivering mitomycin directly into the bladder. Phase III Envision trial results showed a 78% complete response rate at three months, with 79% remaining event-free at 12 months. Common side effects included urinary and laboratory abnormalities; serious events occurred in 12% of patients. UroGen aims to market the treatment starting July 1, with postmarketing commitments ensuring ongoing safety and efficacy evaluation.