FDA Accepts Supplemental NDA for IBTROZI® (taletrectinib) with Updated DoR in Advanced ROS1+ve NSCLC May 12, 2026
FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma May 12, 2026
Fast Track Designation for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma May 12, 2026
US FDA Fast Track Designation for Zocilurtatug Pelitecan (Zoci) for Treatment of Extrapulmonary Neuroendocrine Carcinomas (epNECs) May 12, 2026
FDA Approves BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher May 12, 2026
