Urogen Pharma secured FDA approval for Zusduri (mitomycin) to treat recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer after a narrowly negative advisory committee vote. The approval, driven by robust phase III Envision trial results showing 78% initial complete response and 79% event-free survival at 12 months, offers a nonsurgical treatment alternative to repeated transurethral resections. Despite serious adverse events in 12% of patients, Urogen plans market launch by July and must continue postmarketing surveillance under FDA commitments.