US FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for MIBC Regardless of Cisplatin Eligibility April 21, 2026
Comprehensive response to FDA OPDP submitted regarding issues related to a television advertisement and a podcast for ANKTIVA April 15, 2026
QUILT-2.005 randomized clinical trial on track for final analysis and supplemental BLA submission in 2026 for the BCG-naïve NMIBC carcinoma in situ March 31, 2026
FDA Approves Label Update to Accelerate Thaw Time for ADSTILADRIN® (nadofaragene firadenovec-vncg) March 31, 2026
EMA Validates Type II Variation Application for PADCEV + Keytruda in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer March 24, 2026
NCCN Guidelines Updated to Include ANKTIVA® Plus BCG for Patients With BCG-Unresponsive NMIBC With Papillary-Only Disease March 24, 2026
First-in-human Erda-iDRS (formerly TAR-210) results in intermediate‑risk NMIBC highlighted March 17, 2026
Supplemental BLA for ANKTIVA + BCG in BCG-Unresponsive NMIBC with Papillary Disease Resubmitted to the FDA March 10, 2026
TARA-002 Demonstrates 68% Complete Response Rate at Six Months in BCG-Unresponsive NMIBC March 3, 2026
ZUSDURI™ Achieves Durable Complete Responses Across EORTC Risk Groups in Patients with Recurrent LG-IR-NMIBC March 3, 2026
Perioperative KEYTRUDA + Padcev Reduced Risk of EFS Events by 47% and Risk of Death by 35% for Cisplatin-Eligible MIBC Patients March 3, 2026
SURGE Therapeutics Raises $32M Series B Financing to Advance Intraoperative Immunotherapy to Improve Cancer Patient Survival Outcomes Post-Surgery February 25, 2026
European Commission grants conditional marketing authorization for ANKTIVA + BCG in BCG-unresponsive NMIBC CIS, with or without papillary tumors February 25, 2026
Positive Ph 2 Data for Maveropepimut (MVP-S) + Pembrolizumab and Low-Dose Cyclophosphamide in Metastatic Bladder Cancer Reported February 1, 2026
Updated Interim Data from Ph 2 ADVANCED-2 Trial of TARA-002 in BCG-Unresponsive NMIBC Patients to be Presented January 25, 2026
Regulatory Discussions with FDA on Potential Resubmission Path for ANKTIVA® in BCG-Unresponsive Papillary Bladder Cancer Advanced January 25, 2026
FDA Alignment Received on Registrational Studies Design for NDV-01 for 2L refractory high-grade NMIBC and in intermediate-risk NMIBC in the adjuvant setting January 18, 2026
ANKTIVA® with BCG Demonstrates 96% Survival at Three Years with Median Survival Not Yet Reached in BCG-Unresponsive High-Grade Papillary-Only NMIBC December 22, 2025
PADCEV + Keytruda combo Significantly Improves Survival for MIBC Patients Regardless of Cisplatin Eligibility December 22, 2025
Conditional Marketing Authorization Recommendation from EMA Received for ANKTIVA® with BCG for NMIBC Carcinoma in Situ December 15, 2025
enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness December 9, 2025
Updated Interim Data from Ph 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients Announced December 9, 2025
