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
FDA Clears IND Application for AXN-2510 for a Ph 1 Trial in Relapsed/Refractory Solid Tumors July 8, 2025
FDA approves label updates for Breyanzi and Abecma to reduce certain patient monitoring requirements and removes the Risk Evaluation and Mitigation Strategy (REMS) programs July 1, 2025
FDA grants Priority Review to Supplemental NDA for Revuforj® (revumenib) in R/R mNPM1 AML; PDUFA action date Oct 2025 July 1, 2025
IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of 1L MCL patients eligible for autologous stem cell transplant July 1, 2025
DARZALEX® (daratumumab) receives positive CHMP opinion for patients with high-risk smouldering multiple myeloma July 1, 2025
Additional Tumor-Agnostic Indication of Alecensa for ALK Fusion/Rearrangement Gene-Positive Solid Tumors Including Pediatric Patients Filed July 1, 2025
Positive CHMP Opinion for CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors July 1, 2025
