First-Patient-In Announced for Ph 1 Trial of IDE397 and Trodelvy® Combination in MTAP-Deletion Bladder Cancer July 1, 2024
Unprecedented 82.3% DOR at 12 Months in the ENVISION Trial Investigating UGN-102 as a Non-Surgical Treatment for LG-IR-NMIBC announced June 18, 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer May 15, 2024
Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer May 7, 2024
TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk NMIBC May 7, 2024
Results from ATLAS Showing Robust UGN-102 Durability of Response in New and Recurrent Low-Grade Intermediate-Risk NMIBC Announced May 7, 2024
Three-Year Follow-up Data in BCG-Unresponsive NMIBC Show Durable Response to Treatment with ADSTILADRIN (nadofaragene firadenovec-vncg) in 2 Patient Cohorts April 16, 2024
Positive Surveillance Analysis from the Randomized Ph 3 IMvigor011 Trial in MIBC announced April 8, 2024
China’s NMPA Accepts Supplemental BLA for enfortumab vedotin with KEYTRUDA for 1L Bladder Cancer April 2, 2024
Rolling NDA submitted to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission March 19, 2024
U.S. FDA Approves Opdivo + Cisplatin + Gemcitabine for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma March 12, 2024
KEYTRUDA Significantly Improved DFS as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized MIBC After Surgery February 26, 2024
EMA Validates Type II Variation Application for PADCEV (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for 1L Treatment of Advanced Bladder Cancer February 26, 2024
PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) Granted Priority Review by Japan’s MHLW for 1L Treatment of Advanced Bladder Cancer February 26, 2024
KEYTRUDA Significantly Improved Disease-Free Survival (DFS) as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized Muscle-Invasive and Locally Advanced Urothelial Carcinoma After Surgery January 31, 2024
UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers January 25, 2024
Ferring announces full availability of ADSTILADRIN® (nadofaragene firadenovec -vncg) in the U.S. January 25, 2024
European Commission approves Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types January 23, 2024
ImmunityBio Announces $320 Million Investment by Oberland Capital, with $210 Million Funded at Closing, Bringing Total Financing in 2023 to $850 Million January 10, 2024
First Patient Dosed in Trial Evaluating Efti and BAVENCIO in Metastatic Urothelial Cancer January 10, 2024
FDA Approves Expanded Indication for KEYTRUDA Plus Padcev for 1L Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer December 19, 2023
IDEAYA Announces Clinical Study Collaboration with Gilead Sciences to Evaluate Trodelvy® and IDE397 Combination in MTAP-Deletion Bladder Cancer December 11, 2023
Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer December 11, 2023
