US FDA Approves ZUSDURI™ (mitomycin) for Intravesical Solution for Recurrent Low-Grade Intermediate-Risk NMIBC June 17, 2025
AKEEGA® (niraparib and abiraterone acetate dual-action tablet) improved efficacy in patients with HRR-mutated mHSPC vs. current SoC June 11, 2025
FDA grants Regenerative Medicine Advanced Therapy (RMAT) Designation for CAN-2409 for the Treatment of Prostate Cancer June 3, 2025
Imfinzi recommended for approval in the EU by CHMP as perioperative immunotherapy for MIBC June 3, 2025
Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA+ve metastatic HSPC June 3, 2025
FDA ODAC Votes Against Risk/Benefit Profile of UGN-102 in Recurrent, Low-Grade, Intermediate-Risk NMIBC May 27, 2025
Archeus Technologies and Wisconsin Alumni Research Foundation to Advance ART-101 into Clinical Development for Prostate Cancer May 26, 2025
Successful End of Ph 2 Meeting with US FDA on Ph 3 Registrational Study Design for PT-112 in Patients with Metastatic CRPC Announced May 21, 2025
Ph 3 Trial of Disitamab Vedotin in 1L HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma meets Primary Endpoints of PFS and OS May 21, 2025
FDA Approves Zynyz (retifanlimab-dlwr) for 1L Treatment of Advanced Anal Cancer Patients May 21, 2025
Ph 2 Trial evaluating the efficacy and safety of Lutetium (177Lu) rhPSMA-10.1 Injection initiated in metastatic CRPC May 13, 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
Urgent Meeting With FDA Requested to Address the Change in the Agency’s Unambiguous Guidance to Submit Supplemental BLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter May 13, 2025
Sandoz enters global collaboration license agreement with Henlius to commercialize ipilimumab in multiple indications May 6, 2025
CAPItello-280 Ph 3 trial of Truqap (capivasertib) + docetaxel and ADT in patients with metastatic CRPC to be discontinued May 6, 2025
Initial Data from Ph 3 Trial Demonstrating 75% CRR at 3 Months with nadofaragene firadenove) in BCG-unresponsive Japanese NMIBC Patients Announced April 30, 2025
Sasanlimab Combination Significantly Improves EFS in BCG-Naïve, High-Risk NMIBC, but misses OS endpoint April 30, 2025
FDA Approves Second Drug Product Manufacturing Facility for ADSTILADRIN® (nadofaragene firadenovec-vncg) April 30, 2025
Positive Interim Results Demonstrating Durable Responses in Ongoing Ph 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC Announced April 30, 2025
TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC April 30, 2025
