NMPA Accepts New Drug Applications for Toripalimab Subcutaneous Injection Across 12 Indications March 10, 2026
NMPA approves IND application for HLX97 for the treatment of advanced or metastatic solid tumors March 10, 2026
FDA approves IND application for Ph 1 trial of KGX105 monotherapy in locally advanced or metastatic solid tumors March 10, 2026
FDA approves IND application for KST-0651 for Ph 1 trial in Advanced Solid Tumors including pancreatic cancer, CRC, NSCLC, and others March 10, 2026
FDA approves IND application for GNTbm-38 for Ph 1 trial in Advanced Solid Tumors and R/R PTCL March 10, 2026
IND Application filed for ML-016 for Advanced Solid Tumors with Lung and/or Liver Mets March 10, 2026
FDA Fast Track Designation for ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer March 3, 2026
FDA completes 30-day safety review of two IND applications for CXCR4-targeted theranostic program in hemato-oncology; proposed clinical study may proceed March 3, 2026
ENHERTU® Supplemental NDA Submitted in Japan as Adjuvant Therapy for Patients with HER2 Positive Early Breast Cancer March 3, 2026
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
