DATROWAY® Type II Variation Application Validated in the EU for Patients with 1L Metastatic, IO-ineligible TNBC December 22, 2025
Conditional Marketing Authorization Recommendation from EMA Received for ANKTIVA® with BCG for NMIBC Carcinoma in Situ December 15, 2025
FDA grants Orphan Drug Designation for AJ1-11095 for the Treatment of Myelofibrosis December 15, 2025
FDA Grants Priority Review to supplemental BLA for Opdivo® + Chemo Combo for Classical Hodgkin Lymphoma December 15, 2025
Cadonilimab Receives FDA Clearance for Global Ph 3 1L Gastric Cancer Trial vs. Nivolumab December 15, 2025
Global Registrational Ph 3 Study of Olverembatinib in 1L Ph+ ALL Cleared by FDA and EMA December 9, 2025
Accelerated FDA Strategy to Advance (Z)-Endoxifen Across Breast Cancer Continuum Announced December 9, 2025
IND Clearance and EMA Approval of CTA for Ph 1/2 QUADvance Study of AVC-203 for R/R B-cell malignancies announced December 9, 2025
NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Option for Adult Patients with R/R B-ALL December 2, 2025
HREC provides human ethics approval for HARNESS-1 Ph 1a/b trial of RC220 in patients with EGFR-mutated NSCLC December 2, 2025
BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of R/R Multiple Myeloma Announced December 2, 2025
FDA Grants Fast Track Designation to Zotiraciclib for Treatment of Recurrent High-Grade Glioma with IDH1/2 Mutations December 2, 2025
Fast Track Designation for AVZO-103 for the Treatment of Patients with Urothelial Cancer Previously Treated with Enfortumab Vedotin December 2, 2025
