FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma March 3, 2026
FDA accepts NDA for giredestrant in ESR1-mutated, ER+ advanced breast cancer; PDUFA Dec 2026 February 25, 2026
MHRA and REC approved CTA for Ph 1 ZIMA-101 trial of ZI-MA4-1 in patients with advanced solid cancers February 25, 2026
FDA Clears IND Application for CS2009 (PD-1/VEGF/CTLA-4) to Advance into Ph 2 Clinical Trial February 25, 2026
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer February 25, 2026
IND filed with FDA for Ph 2 study of TBS-2025 for the treatment of R/R mutNPM1 AML in combination with a menin inhibitor February 25, 2026
ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2+ve Early Breast Cancer February 25, 2026
DATROWAY Supplemental NDA Submitted in Japan for Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy February 25, 2026
Adoption of Amended Protocol for Ph 3 VERSATILE-003 Trial Incorporating PFS as Primary Endpoint for Interim Analysis and Potential Accelerated Approval Announced February 25, 2026
FDA grants Breakthrough Therapy Designation, Priority review and accepts NDA for Iberdomide in RRMM Patients; PDUFA Aug 2026 February 25, 2026
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
