Oxford BioTherapeutics Announces Third Oncology Drug Candidate from Boehringer Ingelheim Collaboration Selected to Advance into IND-Enabling Studies July 8, 2025
MHRA approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG-unresponsive NMIBC July 8, 2025
FDA Grants RMAT Designation for Detalimogene in High-Risk, Non-Muscle Invasive Bladder Cancer July 1, 2025
US FDA Approves ZUSDURI™ (mitomycin) for Intravesical Solution for Recurrent Low-Grade Intermediate-Risk NMIBC June 17, 2025
Imfinzi recommended for approval in the EU by CHMP as perioperative immunotherapy for MIBC June 3, 2025
FDA ODAC Votes Against Risk/Benefit Profile of UGN-102 in Recurrent, Low-Grade, Intermediate-Risk NMIBC May 27, 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
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
TAR-200 monotherapy demonstrates highest CRR reported to date with sustained clinical benefits in patients with certain types of bladder cancer April 30, 2025
Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec announced April 30, 2025
TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Ph 2b SunRISe-1 study (Cohort 2) in NMIBC patients April 22, 2025
Supplemental BLA submitted to FDA for use of ANKTIVA® plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease April 22, 2025
Relmada Therapeutics Licenses Ph 2 Bladder Cancer Candidate, NDV-01, from Trigone Pharma April 2, 2025
75.5% CR at any time in Ph 3 study of cretostimogene monotherapy for high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) April 2, 2025
Imfinzi approved in the US as perioperative immunotherapy for patients with muscle-invasive bladder cancer April 2, 2025
IMFINZI perioperative regimen improved EFS and OS across MIBC patients regardless of cPR status in post-hoc exploratory analysis of NIAGARA Ph 3 trial February 19, 2025
Data from Long-Term Follow-up Study to the OLYMPUS Trial that Shows a Median DOR of ~4 Years in Patients Achieving CR with JELMYTO Published in The Journal of Urology February 19, 2025
NDA initiated with US FDA for TAR-200 for patients with BCG-unresponsive high-risk NMIBC January 21, 2025
