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Hypercalcemia of Malignancy 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...
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 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 Medwatch Alert: Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death
ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial. Posting this information does not mean that ...