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
End of Ph 2 Meeting Granted by US FDA for OST-HER2 Program in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma July 8, 2025
Austrian Regulatory Green Light Enables ADC Combination Testing and Ph 1 Site Expansion for ES2B-C001 July 8, 2025
NMPA clears application to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab in 1L metastatic HCC patients July 8, 2025
Submission of extension of indication application to EMA of AKEEGA with prednisone or prednisolone for mHSPC and HRR gene alterations announced July 8, 2025
Confirmatory Ph 3 trial of masitinib in metastatic CRPC authorized by FDA and EMA, with biomarker to target patients with less advanced metastatic disease July 8, 2025
