Incyte Corporation has announced positive topline results from its Phase 3 frontMIND trial evaluating tafasitamab (marketed as Monjuvi/Minjuvi) and lenalidomide in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint of progression-free survival (PFS) and a key secondary endpoint of event-free survival (EFS), setting the stage for […]
Avatar Medical is set to introduce Eonis Vision, a glasses-free 3D medical imaging system, at CES 2026. The product, developed in collaboration with Belgian display specialist Barco and powered by high-performance Dell hardware, is aimed at enhancing the clarity of doctor–patient communication. While the original Avatar Medical Vision software is already FDA-cleared, the updated version […]
XRlabs has disclosed it is integrating NVIDIA Jetson Thor and NVIDIA Isaac for Healthcare to develop an AI-powered retrofit system for surgical visualisation tools, aiming to deliver real-time perception, tool tracking, and intent-aware automation for neurosurgery and other minimally invasive procedures. The system is currently under early-stage clinical evaluation. Unlike traditional surgical robotics or integrated […]
GenEditBio Limited, a Hong Kong–headquartered clinical-stage biotechnology firm focused on in vivo genome-editing therapies, announced that the United States Food and Drug Administration has cleared its Investigational New Drug application for GEB‑101, a CRISPR-based candidate for TGFBI corneal dystrophy. This regulatory milestone authorizes the launch of the Phase 1/2 CLARITY trial in the United States, […]
RevBio Inc. has received approval from the United States Food and Drug Administration to initiate a pilot clinical trial evaluating TETRANITE, its regenerative bone adhesive, for dental ridge augmentation procedures. The trial will examine whether the product can eliminate the need for membranes, meshes, tacks, and fixation screws—elements that have traditionally been considered essential for […]
Island Pharmaceuticals Limited has confirmed that the United States Food and Drug Administration (FDA) continues to evaluate its most recent regulatory submission related to Galidesivir, the company’s clinical-stage antiviral candidate being advanced under the Animal Rule pathway. In correspondence dated 2 January 2026, the regulator informed the Australian biotech firm that additional time is required […]
Johnson & Johnson (J&J) announced that its investigational candidate JNJ-95475939 (JNJ-5939) failed to meet prespecified efficacy criteria in the DUPLEX-AD Phase 2b trial for moderate to severe atopic dermatitis. Following an interim analysis, the study was terminated early. Despite showing a favorable tolerability profile, the molecule did not demonstrate sufficient clinical efficacy to warrant continuation. […]
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.