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
European Commission Approves Subcutaneous Administration of KEYTRUDA® for All Adult Indications Approved in the European Union November 24, 2025
First Patient Dosed in SANTANA-225 Ph 1/2 Trial of 225Ac-SSO110 in Patients with ES-SCLC or MCC 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
Enrollment Completed in SAFFRON Ph 3 Trial of ORPATHYS + TAGRISSO Combo in TAGRISSO-treated EGFRm, MET-overexpressed and/or amplified LA/M NSCLC patients November 10, 2025
GSK5764227 (GSK’227) received Orphan Drug Designation from EMA for the treatment of pulmonary NEC/SCLC November 4, 2025
DESTINY-Lung06 Ph 3 Trial of ENHERTU Initiated as 1L Therapy in Patients with HER2 Overexpressing Metastatic NonSquamous NSCLC November 4, 2025
Updated Elironrasib Safety & Efficacy Data in Patients with KRAS G12C NSCLC Following Treatment with a KRAS(OFF) G12C Inhibitor Presented October 29, 2025
BLA submission planned in Q4 2025 for Ivonescimab based on HARMONi Global Ph 3 Study Results October 29, 2025
First Patient Enrolled in Ph 1 Trial of Tumor-Associated Antigen Cancer Vaccine EVM14 October 21, 2025
First patients enrolled in Ph 1 trial with KQB548 (BAY 3771249) in KRAS G12D-mutated tumors October 21, 2025
Ivonescimab Global Ph 3 Development Program with HARMONi-GI3 Study expanded in 1L CRC October 21, 2025
FDA feedback provided regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti) October 21, 2025
FDA approves IND Application for Ph 2/3 Study of JS207 for the Neoadjuvant Treatment of NSCLC Patients October 21, 2025
Kazia Therapeutics Announces Collaboration and In-Licensing Agreement with QIMR Berghofer for a first-in-class PD-L1 degrader program October 16, 2025
Ph 2 study of BND-22 (SAR444881) + anti-PD-1 therapy in IO-refractory NSCLC or IO-naive MSS-CRC or ovarian cancer to be initiated October 16, 2025
Statistically Significant Final 2-Yr OS Data from Ph 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent Pulmonary Metastatic Osteosarcoma Announced October 15, 2025
