NMPA approves trastuzumab botidotin (A166) for patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapy October 18, 2025
Libtayo® (cemiplimab-rwlc) Approved in US for Adjuvant Treatment of CSCC with a High Risk of Recurrence After Surgery and Radiation October 15, 2025
FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer September 30, 2025
FDA Approves SC KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection Across Most Solid Tumor Indications for KEYTRUDA September 23, 2025
European Commission Approves VORANIGO® (vorasidenib) for Grade 2 IDH-Mutant Glioma September 23, 2025
HERNEXEOS® approved in China for previously treated patients with HER2-mutant advanced NSCLC September 3, 2025
ENHERTU® Approved in Japan for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following at Least One Endocrine Therapy September 3, 2025
Hong Kong Department of Health approves TIVDAK (tisotumab vedotin-tftv) in Hong Kong for patients with recurrent or metastatic cervical cancer September 3, 2025
DATROWAY® Approved in China for Patients with Previously Treated Metastatic HR+ve, HER2-neg Breast Cancer September 3, 2025
FDA approved CAMCEVI ETM long-acting injectable formulation for advanced prostate cancer September 3, 2025
European Commission Approves Tablet Formulation of BRUKINSA® for All Approved Indications August 26, 2025
U.S. FDA grants accelerated approval to HERNEXEOS® for previously treated patients with HER2-mutant advanced NSCLC August 12, 2025
U.S. FDA Approves Modeyso™ (dordaviprone) for Recurrent H3 K27M-mutant Diffuse Midline Glioma August 11, 2025
European Commission Approval for CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors August 5, 2025
European Commission approves Itovebi for people with ER+ve HER2neg advanced breast cancer with a PIK3CA mutation July 29, 2025
Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma July 29, 2025
Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma July 29, 2025
Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma July 29, 2025
Opdivo® IV Infusion Approved in Taiwan in Combination with Yervoy® for Unresectable or Metastatic 1L HCC July 29, 2025
Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma July 29, 2025
Nubeqa™ (darolutamide) receives EU approval for patients with metastatic HSPC based on positive results from the pivotal Ph 3 ARANOTE trial July 23, 2025
