RMAT Designation Granted by FDA to KB707 for the Treatment of Advanced or Metastatic NSCLC February 17, 2026
FDA cleared IND application for NPX372 in B7-H7–expressing solid tumors, including lung adenocarcinoma, RCC, and pancreatic adenocarcinoma February 17, 2026
Zenocutuzumab‑zbco Receives FDA Orphan Drug Designation for Treatment of Cholangiocarcinoma February 9, 2026
FDA clears IND application for Ph 1 study for PRT12396 for the treatment of patients with myeloproliferative neoplasms February 9, 2026
FDA clears IND application for Ph 1 study of GTB-5550 TriKE for Solid Tumors Expressing B7-H3 February 9, 2026
Zovegalisib Granted Breakthrough Therapy Designation by FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer February 9, 2026
FDA clears IND application for Ph 1 study of N17350 in patients with advanced solid tumors February 9, 2026
FDA Accepted NDA for Zanzalintinib – Tecentriq Combo in Patients with Metastatic CRC February 9, 2026
DATROWAY® Granted Priority Review in the US in 1L Metastatic TNBC Patients Who Are Not Candidates for Immunotherapy February 9, 2026
IBI3003 Receives FDA Fast Track Designation for Relapsed or Refractory Multiple Myeloma February 1, 2026
Trodelvy® Added as Preferred Regimen Within 1L Metastatic TNBC in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) February 1, 2026
Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for GIST Patients February 1, 2026
FDA Orphan Drug Designation for CTD402 for the Treatment of T-Cell Leukemia and Lymphoma February 1, 2026
FDA Accepts BLA for Ivonescimab + Chemo in EGFRm NSCLC Post-TKI Therapy; PDUFA Nov 2026 February 1, 2026
