JSKN003 Received FDA IND Approval to Initiate Ph 2 Study for Platinum-Resistant Ovarian Cancer August 5, 2025
NMPA and FDA approve initiation of Ph 2 trial (COMPASSION-36/AK104-225) of cadonilimab combo in previously treated HCC patients August 5, 2025
FDA Clears IND application for Ph 1/2 Trial of ABT-301 Triplet Therapy for Advanced CRC August 5, 2025
Imfinzi granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and GEJ cancers July 29, 2025
Positive CHMP Opinion for VORANIGO® (vorasidenib) for the Treatment of Adults and Adolescents with Grade 2 IDH-mutant Diffuse Glioma July 29, 2025
NMPA accepts NDA for sevabertinib (BAY 2927088) for previously treated NSCLC patients with HER2/ERBB2 mutations July 29, 2025
FDA Breakthrough Therapy Designation for Elironrasib for KRAS G12C-mutated locally advanced or metastatic NSCLC July 29, 2025
US FDA extends review period for Blenrep (belantamab mafodotin-blmf) in R/R multiple myeloma July 29, 2025
Regulatory Update on Clinical Development Plan for Muzastotug in MSS-CRC Announced Following Productive Type B (End of Ph 1) Meeting with FDA July 23, 2025
FDA issues CRL for Supplemental BLA for Columvi® (glofitamab-gxbm) + GemOx combo for R/R DLBCL patients not candidates for autoSCT July 23, 2025
FDA ODAC voted against the overall benefit/risk profile of Blenrep (belantamab mafodotin-blmf) combo in R/R multiple myeloma July 23, 2025
ENHERTU + Pertuzumab Granted Breakthrough Therapy Designation in the US as 1L Therapy for Patients with HER2+ve Metastatic Breast Cancer July 23, 2025
