PADCEV™ + KEYTRUDA™ combo Significantly Improves Survival before and after SOC (surgical cystectomy) in cisplatin-ineligible MIBC patients September 16, 2025
Robust 24-month CR rate of 41.8% observed for cretostimogene monotherapy in BCG-unresponsive high-risk NMIBC patients September 9, 2025
PADCEV Plus KEYTRUDA Significantly Improves Survival for Cisplatin-ineligible MIBC Patients When Given Before and After Surgery August 19, 2025
IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit August 19, 2025
24-Month DOR of 72.2% Announced from Ph 3 ENVISION Trial of ZUSDURI in Recurrent Low-Grade Intermediate-Risk NMIBC August 12, 2025
Ph 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent LGIR-NMIBC published in Reviews in Urology July 29, 2025
Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI™ in Patients with LGIR NMIBC Announced July 23, 2025
Enrollment completed in Ph 3 UTOPIA Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk NMIBC July 15, 2025
Imfinzi approved in the EU for muscle-invasive bladder cancer based on data from NIAGARA Ph 3 trial July 8, 2025
Oxford BioTherapeutics Announces Third Oncology Drug Candidate from Boehringer Ingelheim Collaboration Selected to Advance into IND-Enabling Studies July 8, 2025
MHRA approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG-unresponsive NMIBC July 8, 2025
FDA Grants RMAT Designation for Detalimogene in High-Risk, Non-Muscle Invasive Bladder Cancer July 1, 2025
US FDA Approves ZUSDURI™ (mitomycin) for Intravesical Solution for Recurrent Low-Grade Intermediate-Risk NMIBC June 17, 2025
Imfinzi recommended for approval in the EU by CHMP as perioperative immunotherapy for MIBC June 3, 2025
FDA ODAC Votes Against Risk/Benefit Profile of UGN-102 in Recurrent, Low-Grade, Intermediate-Risk NMIBC May 27, 2025
Imfinzi regimen demonstrated statistically significant DFS improvement in high-risk NMIBC in POTOMAC Ph 3 trial May 13, 2025
FDA Advisory Committee Announced for UGN-102 for Recurrent Low-Grade Intermediate-Risk NMIBC May 13, 2025
Urgent Meeting With FDA Requested to Address the Change in the Agency’s Unambiguous Guidance to Submit Supplemental BLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter May 13, 2025
Initial Data from Ph 3 Trial Demonstrating 75% CRR at 3 Months with nadofaragene firadenove) in BCG-unresponsive Japanese NMIBC Patients Announced April 30, 2025
Sasanlimab Combination Significantly Improves EFS in BCG-Naïve, High-Risk NMIBC, but misses OS endpoint April 30, 2025
FDA Approves Second Drug Product Manufacturing Facility for ADSTILADRIN® (nadofaragene firadenovec-vncg) April 30, 2025
Positive Interim Results Demonstrating Durable Responses in Ongoing Ph 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC Announced April 30, 2025
