FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of NSCLC October 6, 2026
NDA Submission Initiated for Zipalertinib + Chemo in 1L EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program October 6, 2026
FDA IND clearance for Ph 1 trial of CUR-001 in mesothelin-positive advanced refractory solid tumours October 6, 2026
SOT106 granted fast Track Designation in osteosarcoma and orphan Drug Designation granted in soft tissue sarcoma October 1, 2026
Ifinatamab Deruxtecan BLA for Certain Patients with Previously Treated ES-SCLC Voluntarily Withdrawn October 1, 2026
Perioperative Imfinzi plus neoadjuvant enfortumab vedotin granted Priority Review in the US for MIBC patients October 1, 2026
MAA submitted to EMA for Lirafugratinib for Advanced/Metastatic Cholangiocarcinoma (CCA) Harboring FGFR2 Fusions or Rearrangements September 22, 2026
SYS6010 granted breakthrough therapy designation by NMPA in China for patients with actionable genomic alteration-negative non-squamous NSCLC September 22, 2026
Positive EU CHMP Opinion for KEYTRUDA + Padcev as Perioperative Treatment for Adults With Resectable MIBC September 22, 2026
Enhertu recommended for approval in the EU by CHMP as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer September 22, 2026
