FDA Granted Fast Track Designation for AVZO-1418 for the Treatment of Patients with EGFR-Mutated TKI-Pretreated NSCLC November 18, 2025
FDA alignment secured on planned Ph 3 NDV-01 program in 2L BCG-unresponsive NMIBC patients and Intermediate risk NMIBC in the adjuvant setting November 10, 2025
GSK5764227 (GSK’227) received Orphan Drug Designation from EMA for the treatment of pulmonary NEC/SCLC November 4, 2025
FDA Meeting Requested to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer November 4, 2025
FDA grants non-transferrable voucher for daraxonrasib (RMC-6236) under the Commissioner’s National Priority Voucher (CNPV) pilot program October 29, 2025
Zenocutuzumab-zbco Granted FDA Breakthrough Therapy Designation for NRG1+ Cholangiocarcinoma October 29, 2025
FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX™, Each in Combination with Padcev, for Cisplatin-ineligible Patients with MIBC October 29, 2025
Rare Pediatric Disease Designation from FDA for Iopofosine I 131 in R/R Pediatric High-Grade Glioma October 29, 2025
Type C meeting with FDA requested to discuss OS findings in 1L GBM patients treated with paxalisib and to discuss potential regulatory pathway per OCE’s Project FrontRunner initiative October 29, 2025
BLA submission planned in Q4 2025 for Ivonescimab based on HARMONi Global Ph 3 Study Results October 29, 2025
