PRINCETON, N.J.--(BUSINESS WIRE)--UroGen (NASDAQ: URGN), a biotech company dedicated to developing a...

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC. The ODAC meeting w.

URGN

UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

URGN's UGN-102 NDA will be reviewed by the FDA on May 21, 2025.
The ODAC decision could significantly impact URGN's market position.

urogen-announces-fda-advisory-committee-for-ugn-102-an-investigational-treatment-for-recurrent-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer

UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

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