Curasight A/S has dosed the first patient in a Phase 1 clinical trial of uTREAT for glioblastoma, launching the therapeutic half of its uPAR-targeting theranostic platform alongside its companion diagnostic, uTRACE, which is already in Phase 2 for prostate cancer. How curative ambitions shift when a theranostic platform enters human testing in glioblastoma Curasight’s advancement
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
Find out how Diamyd Medical is accelerating its type 1 diabetes Phase 3 trial after FDA alignment—what this means for approval, adoption, and risk.
Kallisio has begun clinical implementation of its FDA-cleared Stentra system at Stanford Health Care, marking the first reported integration of the patient-specific intraoral device into a major U.S. hospital’s workflow for head and neck cancer radiation therapy. The system, which received 510(k) clearance in January 2024, enables individualized immobilization of oral structures during intensity-modulated radiation
GenSight Biologics S.A. has received approval from Israel’s Ministry of Health to provide early access treatment with its investigational gene therapy GS010/LUMEVOQ (lenadogene nolparvovec) for individual patients diagnosed with ND4-related Leber Hereditary Optic Neuropathy (LHON). This authorization permits bilateral intravitreal injections under compassionate use protocols, with treatments expected to begin in the first quarter of
RevBio Inc. has received clearance from the United States Food and Drug Administration to begin a pilot clinical trial of TETRANITE, its regenerative bone adhesive, for dental ridge augmentation. The study will assess the product’s ability to support bone grafting procedures without the use of membranes, meshes, tacks, or screws—offering a potential simplification to a
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
Samsung Bioepis has officially begun direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across Europe following the complete transfer of rights from Biogen. The move makes BYOOVIZ the fourth biosimilar now independently marketed by Samsung Bioepis in the region, joining EPYSQLI (eculizumab), OBODENCE (denosumab), and XBRYK (denosumab). The company also confirmed that a pre-filled
Bebird, the consumer-focused smart health technology firm, has officially launched the EarSight Ultra X, a next-generation ear care device featuring real-time 5G connectivity, 4K endoscopy imaging, and multiple safety enhancements tailored for family use. Positioned as a proactive wellness solution rather than a regulated diagnostic tool, the product aims to bring clinical-grade visualization into home