FDA alignment secured on planned Ph 3 NDV-01 program in 2L BCG-unresponsive NMIBC patients and Intermediate risk NMIBC in the adjuvant setting November 10, 2025
FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX™, Each in Combination with Padcev, for Cisplatin-ineligible Patients with MIBC October 29, 2025
ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent LG-IR NMIBC October 7, 2025
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
