mAbxience and Amneal Pharmaceuticals have secured U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars, Boncresa and Oziltus, referencing Prolia and XGEVA respectively, clearing a long-anticipated regulatory hurdle in osteoporosis and oncology supportive care. The approvals position Amneal Pharmaceuticals as the exclusive U.S. commercial partner, with mAbxience responsible for development and manufacturing, marking […]
Bracco Imaging S.p.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion supporting the use of Vueway gadopiclenol in pediatric patients from birth. The recommendation extends an existing European Union authorization and places the macrocyclic gadolinium-based contrast agent into one of the […]
Incyte Biosciences Japan has secured approval from the Ministry of Health, Labour and Welfare for the use of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma. This marks the first regulatory authorization in Japan for a CD19-directed therapy in this indication and introduces a novel CD19–CD20 […]
BrainSpace, a U.S.-based medical technology company, has received 510(k) clearance from the U.S. Food and Drug Administration for Intellidrop, a fully automated cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring system. The cleared indication covers ventricular or lumbar use in patients requiring external CSF drainage and continuous pressure monitoring—making it potentially relevant across a […]
BioAtla and GATC Health advance Ozuriftamab Vedotin into a Phase 3 trial for OPSCC via SPV financing. Discover how this targets cancer and aging together.
INBS teams up with Syrma Johari to cut device costs, expand global output, and prep for a 2026 U.S. launch. Find out what this changes for fingerprint drug testing.
FDA rejects Outlook Therapeutics’ ONS-5010 for wet AMD again. Find out what this means for U.S. approval and how European expansion could reshape strategy.
XORTX is using new genetic research to strengthen its case for oxypurinol in gout and kidney disease. Find out how this could shape the future of precision nephrology.
