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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 ...
Medscape

FDA Bucks Advisors to Approve Mitomycin for Non-Muscle Invasive Bladder Cancer

The FDA has approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The intravesical mitomycin formulation is ...
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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 ...
Cure Today

FDA Approves UGN-102 For Some With Bladder Cancer

The FDA has granted approval to UGN-102 for use in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer. The U.S. Food and Drug Administration has approved UGN-102 (mitomycin ...
Cure Today

Zusduri Shows Durable Response in Non–Muscle-Invasive Bladder Cancer

Zusduri demonstrated a 72.2% 24-month response durability in LG-IR-NMIBC patients, leading to FDA approval as a non-surgical treatment option. The ENVISION trial enrolled 240 patients, focusing on ...