FDA Fast Track designation granted to ZW191 for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC) March 31, 2026
Japan’s PMDA approves Initiation of Clinical Trial for CAR-T Therapy Equecabtagene Autoleucel in 2L/3L Multiple Myeloma March 31, 2026
Israeli Ministry of Health approves initiation of Ph 2/3 trial of SIL204 for the treatment of locally advanced pancreatic cancer March 31, 2026
FDA Accepts NDA Resubmission for Rivoceranib in Combination with Camrelizumab for 1L HCC March 31, 2026
FDA Approves Label Update to Accelerate Thaw Time for ADSTILADRIN® (nadofaragene firadenovec-vncg) March 31, 2026
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
