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
NDA submitted for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer July 15, 2025
End of Phase 2 Meeting with FDA scheduled for August 27, 2025 to review OST-HER2 recurrent, pulmonary metastatic osteosarcoma program July 15, 2025
Type C meeting with the FDA requested to discuss the D-MNA product development and gain further alignment on the clinical pathway July 15, 2025
FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic CRPC July 15, 2025
Supplemental NDA for INQOVI (decitabine & cedazuridine) + venetoclax for 1L AML adults ineligible for intensive induction chemo accepted by FDA July 15, 2025
