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
TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer December 11, 2023
FDA Accepts for Priority Review Application for Opdivo + Cisplatin-Based Chemo for the 1L Treatment of Adult Patients with Unresectable/Metastatic urothelial carcinoma December 11, 2023
New Data Show Durable Response Following Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) December 11, 2023
FDA Grants Priority Review to Supplemental BLA for KEYTRUDA Plus PADCEV for the 1L Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer December 4, 2023
Subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types December 4, 2023
Resubmission of BLA for N-803 + BCG for the treatment of BCG-unresponsive NMIBC accepted; new PDUFA date of April 23, 2024 October 31, 2023
First Patients Dosed in First-in-Human Ph 1 Study of FX-909 in Advanced Solid Tumors, Including Urothelial Cancer October 25, 2023
KEYTRUDA® Met Primary Endpoint of DFS in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery October 11, 2023
First Patient in Ph 1b/2 ADVANCED-2 Trial of TARA-002 in NMIBC Patients with High Grade Carcinoma in Situ September 26, 2023
PADCEV and KEYTRUDA Significantly Improve OS and PFS in Patients With Previously Untreated Advanced Bladder Cancer in Ph 3 EV-302 Trial September 26, 2023
Ph 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of OS and PFS in Certain Patients With 1L Locally Advanced or Metastatic Urothelial Cancer September 26, 2023
