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Xgeva News
FDA Approves Bomyntra (denosumab-bnht), a Biosimilar to Xgeva
LAKE ZURICH, Ill., March 27, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilar Bomyntra (denosumab-bnht) of its operating company Fresenius Kabi...
FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva
JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ – Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Osenvelt (CT-P41, denosumab-bmwo), a biosimilar referencing...
Monthly News Roundup - February 2025
FDA Updates Izervay Label to Lengthen Treatment Duration for Geographic Atrophy Izervay (avacincaptad pegol) from Astellas is now FDA-approved without a limitation on duration of dosing, allowing...
FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva
INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Xbryk (de...
Denosumab Increases Cardiovascular Risk in Dialysis-Dependent Patients
TUESDAY, Jan. 7, 2025 – For dialysis-dependent patients treated for osteoporosis, denosumab is associated with a greater preventive effect on fractures but an increased risk for major adverse...
Risk for Emergently Treated Hypocalcemia With Denosumab Rises With CKD Stage
TUESDAY, Nov. 19, 2024 – For patients with chronic kidney disease (CKD), the risk for emergently treated hypocalcemia with denosumab increases with worsening CKD stage, according to a study...
FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...
FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
THOUSAND OAKS, Calif., Dec. 8, 2014 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Xgeva (denosumab) for the...
FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone
June 13, 2013 – The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and...