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Ifinatamab Deruxtecan BLA for Certain Patients with Previously Treated ES-SCLC Voluntarily Withdrawn October 1, 2026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
FDA clears new IND for GTB-5550 in multiple myeloma (MM) under an investigator sponsored trial (IST) protocol September 22, 2026
US FDA Breakthrough Therapy Designation for RASONQUE™ (daraxonrasib) + Chemo for 1L Metastatic Pancreatic Cancer September 22, 2026
FDA approves supplemental NDA for IBTROZI® (taletrectinib) for the treatment of locally advanced or metastatic ROS1+ NSCLC September 22, 2026
End-of-Phase 1 Meeting with FDA and Receipt of Fast Track Designation for LYT-200 in R/R High-Risk MDS Announced September 22, 2026
FDA clears IND application to initiate Ph 1 study for PRT13722 for HR+/HER2- breast cancer patients September 16, 2026
FDA “Study May Proceed” Notice and IND Clearance Received for the Evaluation of TBS-2025 in Molecularly Defined Subsets of AML and Other Blood-Related Cancers September 16, 2026
