FDA granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG) April 7, 2026
FDA granted Fast Track designation for A2B543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression April 7, 2026
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
