PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company focused on urothelial and specialty cancers, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for ZUSDURI, the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI, utilizing UroGen's proprietary sustained release RTGel® technology, consists of mitomycin and sterile hydrogel designed for potent tumor ablation. This landmark approval is based on positive results from the Phase 3 ENVISION trial, which demonstrated a 78% complete response rate at 3 months, with 79% of those patients remaining event-free 12 months later. This approval marks a significant advancement in the treatment of bladder cancer, providing an FDA-approved option for the estimated 59,000 U.S. patients facing recurrent LG-IR-NMIBC each year.