FDA granted Orphan Drug Designation to AMXT 1501 in combination with difluoromethylornithine (DFMO) for the treatment of malignant glioma March 17, 2026
Supplemental BLA for ANKTIVA + BCG in BCG-Unresponsive NMIBC with Papillary Disease Resubmitted to the FDA March 10, 2026
Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2+ve early breast cancer March 10, 2026
Positive CHMP opinion for Ojemda monotherapy for pediatric R/R BRAF-altered pediatric low-grade glioma March 10, 2026
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
