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Denosumab 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 Conexxence (denosumab-bnht), a Biosimilar to Prolia
LAKE ZURICH, Ill., March 27, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilar Conexxence (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...
FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia
JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ – Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo (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...
FDA Approves Ospomyv (denosumab-dssb), a Biosimilar to Prolia
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 Ospomyv (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 Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an i...
FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an i...
FDA Medwatch Alert: Drug Safety Communication: Prolia (denosumab) - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
January 19, 20204 – Based on a completed FDA review of available information, FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low...
FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis
THOUSAND OAKS, Calif., May 21, 2018 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia (denosumab) for the treatment...
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...