Conditional Marketing Authorization Recommendation from EMA Received for ANKTIVA® with BCG for NMIBC Carcinoma in Situ December 15, 2025
FDA approves AKEEGA® for BRCA2m metastatic CSPC with 54% reduction in disease progression vs SOC December 15, 2025
enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness December 9, 2025
Encouraging Efficacy and Safety Profile from Ongoing Ph 1 Trial for JANX007 in mCRPC Announced December 9, 2025
Updated Interim Data from Ph 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients Announced December 9, 2025
MVR-T3011 Latest Clinical Results in BCG-Unresponsive NMIBC Patients Demonstrate High Response December 9, 2025
INLEXZO™ (gemcitabine intravesical system) delivers 74% DFS at one year in BCG-unresponsive, high-risk, papillary-only NMIBC December 9, 2025
The Annals of Oncology Publishes Results of Ph 2 Study of Sacituzumab Tirumotecan Monotherapy for Urothelial Carcinoma December 2, 2025
Fast Track Designation for AVZO-103 for the Treatment of Patients with Urothelial Cancer Previously Treated with Enfortumab Vedotin December 2, 2025
Statistical analysis of primary efficacy endpoints in Ph 2 trial conducted of MCS-8 (PCP) in prostate cancer completed November 24, 2025
FDA Approves KEYTRUDA® and KEYTRUDA QLEX™ (berahyaluronidase alfa-pmph formulation), Each with Padcev®, as Perioperative Treatment for Adults with Cisplatin-Ineligible MIBC November 24, 2025
77.8% Three-Month Complete Response Rate Reported from Ph 3 UTOPIA Trial of UGN-103; FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Received November 10, 2025
Development of UGN-301 (zalifrelimab) to discontinue following completion of Ph 1 dose escalation study November 10, 2025
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
KEYTRUDA + WELIREG Met Primary Endpoint of DFS in Certain Patients With Clear Cell RCC Following Nephrectomy November 4, 2025
WELIREG + LENVIMA Met Primary Endpoint of PFS in Certain Previously Treated Patients With Advanced RCC November 4, 2025
FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX™, Each in Combination with Padcev, for Cisplatin-ineligible Patients with MIBC October 29, 2025
Results for HLD-0915 Demonstrate Encouraging Safety and Anti-Tumor Activity in Metastatic CRPC October 29, 2025
US FDA Priority Review for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) in BRCA-mutated metastatic CSPC October 21, 2025
