Enhertu granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer December 30, 2025
Positive Scientific Advice from EMA on the Design of a Ph 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Announced December 30, 2025
CTA submitted in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101) for Solid Tumors December 22, 2025
IND Application to Initiate a Ph 1 Trial of ABP-102/CT-P72 for HER2-positive Cancers submitted to the US FDA December 22, 2025
Successful Type C Meeting with US FDA Regarding Ph 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Announced December 22, 2025
TECVAYLI® plus DARZALEX FASPRO® combination selected for Commissioner’s National Priority Voucher Pilot program December 22, 2025
FDA approves IND to start a Ph 1/2 trial for PM54 + immunotherapy combo in advanced solid tumors December 22, 2025
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
