FDA Accepts Supplemental BLA for ANKTIVA + BCG in BCG-Unresponsive NMIBC with Papillary Disease; PDUFA Jan 2027 May 26, 2026
Positive EU CHMP Opinion for KEYTRUDA + Padcev as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable MIBC May 26, 2026
Supplemental NDA submitted in Japan for PADCEV + Keytruda in Cisplatin-Eligible Patients with MIBC May 21, 2026
Updated Interim Results Announced From Ph 2 LEGEND trial of detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC patients with CIS with or without concomitant papillary disease May 21, 2026
ZUSDURI Median DOR Still Not Reached with 64.5% 36-month Duration of Response in the Pivotal ENVISION Trial May 21, 2026
Perioperative Imfinzi plus neoadjuvant EV showed statistically significant EFS/OS improvements in MIBC in Ph 3 VOLGA trial May 21, 2026
Positive Updated 12-Month Data Demonstrated Durable Responses in BCG-Naïve Cohort of Ph 2 ADVANCED-2 Trial of TARA-002 in NMIBC May 21, 2026
94.5% Six-Month Duration of Response reported from Ph 3 UTOPIA Trial of UGN-103 Toward Potential Approval in Recurrent Low-Grade Intermediate-Risk NMIBC May 21, 2026
Re-induction with ADSTILADRIN resulted in complete responses in 31% of initial non-responders with BCG-unresponsive NMIBC May 21, 2026
Updated Interim Results Announced From LEGEND Cohort of detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC patients with CIS with or without concomitant papillary disease May 12, 2026
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
