The U.S. Food and Drug Administration (FDA) has issued a black box warning — reserved for the most serious safety issues — for the osteoporosis drug denosumab, sold under the brand name Prolia.
Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. The U.S. regulator has added a new ...
NEW YORK (Reuters) - The U.S. Food and Drug Administration approved on Tuesday the sale of Amgen Inc's osteoporosis drug Prolia to help prevent fractures in post-menopausal women just days after the ...
The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These denosumab ...
Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and ...
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