FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer Concluded March 24, 2026
EMA Validates Type II Variation Application for PADCEV + Keytruda in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer March 24, 2026
FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma March 24, 2026
Positive End-of-Phase 2 Meeting with FDA Regarding the Design of a Ph 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma Announced March 24, 2026
NCCN Guidelines Updated to Include ANKTIVA® Plus BCG for Patients With BCG-Unresponsive NMIBC With Papillary-Only Disease March 24, 2026
Type A meeting with FDA scheduled to discuss the CRL to the BLA for tabelecleucel (tab-cel) March 17, 2026
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
