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
FDA Grants RMAT Designation for Detalimogene in High-Risk, Non-Muscle Invasive Bladder Cancer July 1, 2025
FDA grants Fast Track Designation for SGR-1505 for the Treatment of R/R Waldenström Macroglobulinemia July 1, 2025
Update on U.S. Regulatory Review of TALZENNA in Combination with XTANDI for Broader Use in Metastatic CRPC Provided June 25, 2025
FDA Breakthrough Therapy Designation for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer with KRAS G12 Mutations June 24, 2025
FDA grants Orphan Drug Designation to ADoBind MC001 for the treatment of pancreatic cancer June 24, 2025
Breakthrough Therapy Designation application for oral gallium maltolate (GaM) in refractory brain tumors voluntarily withdrawn and resubmitted June 24, 2025
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma June 24, 2025
