AIM ImmunoTech Secures Broad US Patent for Rintatolimod (Ampligen®) Used in Combination with Keytruda, Expanding Oncology IP Protection for Ampligen Through 2039 September 9, 2026
FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC July 15, 2026
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
