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
Anaptys Announces Intent to Separate Biopharma Operations from Substantial Royalty Assets by Year-end 2026 October 7, 2025
ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent LG-IR NMIBC October 7, 2025
SOPHiA GENETICS Expands Collaboration with AstraZeneca to Enhance Detection of Breast and Prostate Cancer September 23, 2025
Positive Interim Efficacy Analysis of Ph 2 Trial of ENV105 in Advanced Prostate Cancer with Median PFS of Over One Year Announced September 23, 2025
PADCEV™ + KEYTRUDA™ combo Significantly Improves Survival before and after SOC (surgical cystectomy) in cisplatin-ineligible MIBC patients September 16, 2025
Enrollment of Ph 1 TRE-515 Dose Escalation Trial for Patients with Solid Tumors Completed 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
Positive Data From Ph 1/2 Combo Trial of IDE397 and Trodelvy® in MTAP-Deletion Urothelial Cancer Announced September 9, 2025
