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Xgeva News
FDA Grants Interchangeable Designation to Fresenius Kabi’s Biosimilars Conexxence and Bomyntra (denosumab-bnht)
LAKE ZURICH, Ill., October 29, 2025 – Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the ...
FDA Grants Interchangeability Designation to Celltrion's Denosumab Biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo)
INCHEON, South Korea, Oct. 30, 2025 /PRNewswire/ – Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated Stoboclo (denosumab-bmwo) and O...
FDA Approves Xtrenbo (denosumab- qbde), a Biosimilar to Xgeva
Budapest, Hungary and London, UK, 29 September 2025 – Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) ann...
FDA Approves Aukelso (denosumab-kyqq), a Biosimilar to Xgeva
BENGALURU, India and BRIDGEWATER, N.J., Sept. 17, 2025 /PRNewswire/ – Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE:...
FDA Approves Bilprevda (denosumab-nxxp), a Biosimilar to Xgeva
SHANGHAI, China & JERSEY CITY, NJ – September 2, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved Bil...
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...
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...