FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced CSCC December 2, 2025
Gedatolisib NDA submission to FDA in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer completed November 24, 2025
FDA aligned on the design of pivotal study of pelareorep + SOC for 1L treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) November 24, 2025
FDA Accepts NDA for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC November 24, 2025
Rolling Submission of NDA to FDA initiated for Zipalertinib for Treatment of Locally Advanced or Metastatic NSCLC with EGFR Exon 20 Insertion Mutations November 24, 2025
NDA accepted; PDUFA Date announced for n.c.a. 177Lu-edotreotide (ITM-11) in GEP-NETs November 18, 2025
MHRA Approves CTA for YntraDose™ in unresectable Locally Advanced Pancreatic Cancer (uLA-PDAC) November 18, 2025
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
