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FDA Grants Priority Review to TAR-200 in BCG-Unresponsive High-Risk NMIBC
FDA Grants Priority Review to TAR-200 in BCG-Unresponsive High-Risk NMIBC

July 17th 2025

Phase 2b SunRISe-1 trial findings supported the FDA to grant priority review to TAR-200 in BCG-unresponsive high-risk NMIBC with carcinoma in situ.

The phase 3 UTOPIA trial has enrolled a total of 99 patients with low-grade intermediate-risk NMIBC to receive UGN-103.
Patient Enrollment for Phase 3 UGN-103 Trial in LG-IM-NMIBC Complete

July 7th 2025

Use of the novel artificial intelligence–based test may provide a painless, low-cost alternative in bladder cancer screening.
AI-Based Urine Test Earns FDA Breakthrough Device Status in Bladder Cancer

July 1st 2025

Detalimogene voraplasmid demonstrated a 71% any-time CR rate in this non-muscle invasive bladder cancer population in the phase 1/2 LEGEND trial.
FDA Grants RMAT Designation to Detalimogene in BCG-Unresponsive NMIBC

June 26th 2025

Data from the phase 3 ENVISION trial support the FDA approval of the mitomycin solution for patients with recurrent, low-grade, intermediate-risk NMIBC.
FDA Approves Mitomycin Solution in Low-Grade Intermediate-Risk NMIBC

June 12th 2025

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Jun Gong, MD, spoke with CancerNetwork® about the latest research from the journal ONCOLOGY® on elderly patients with muscle-invasive bladder cancer.

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