Monthly Prescribing Reference

Novel Mitomycin Formulation Under Review for Bladder Cancer

The PDUFA target date was set for June 13, 2025. The Food and Drug Administration (FDA) announced that it has accepted the New Drug Application (NDA) for UGN-102 for intravesical solution for the ...
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U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive ...

PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today ...
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Mitomycin plus BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: A randomized phase 3 trial (ANZUP 1301).

NAPOLI 3, a phase 3 study of NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final overall survival (OS) analysis and characteristics of the long-term survivors.
Business Wire

UroGen Announces New Data Presentations at the Society of Urologic Oncology 2024 Annual Meeting Highlighting Urothelial Cancer Portfolio Aimed at Addressing Unmet Needs

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, ...
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ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent Low-Grade, Intermediate-Risk Non–Muscle ...

PRINCETON, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty ...
Monthly Prescribing Reference

Zusduri Approved for Recurrent Low-Grade Intermediate-Risk NMIBC

Zusduri is expected to be available on or around July 1, 2025. The Food and Drug Administration (FDA) has approved Zusduri (mitomycin intravesical solution) for adults with recurrent low-grade ...
Cure Today

FDA Accepts New Drug Application for UGN-102 in Bladder Cancer

UGN-102 could become the first FDA-approved treatment for low-grade intermediate-risk non-muscle-invasive bladder cancer, with a PDUFA goal date of June 13, 2025. The phase 3 ENVISION trial ...
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First Patient Dosed in Phase 3 Clinical Trial of UGN-103, a Next Generation Mitomycin-Based Formulation in Development for the Treatment of Low-Grade Intermediate-Risk Non ...

PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today ...