European Commission Approves KEYTRUDA® + Padcev® as Perioperative Treatment for Adults With Resectable MIBC October 27, 2026
Ph 3 Data Shows 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® + BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors October 20, 2026
FDA Expands ANKTIVA® Approval for BCG-Unresponsive NMIBC to Cover Both Papillary and CIS Disease October 20, 2026
Perioperative Imfinzi plus neoadjuvant enfortumab vedotin granted Priority Review in the US for MIBC patients October 1, 2026
Positive EU CHMP Opinion for KEYTRUDA + Padcev as Perioperative Treatment for Adults With Resectable MIBC September 22, 2026
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
