A blockbuster Amgen drug for osteoporosis now carries the FDA’s strictest warning that its use can lead to dangerously low levels of calcium in the blood. This complication, hypocalcemia, is a ...
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 ...
--Amgen today announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the U.S. medicare program showing Prolia ® injection reduced fracture ...
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.
FDA’s boxed warning on denosumab follows study results showing increased and early risks of severe hypocalcemia in patients on dialysis. The Food and Drug Administration (FDA) has added a new boxed ...
Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ...
Findings showed treatment with Prolia significantly increased the risk of developing severe hypocalcemia compared with bisphosphonates, especially in patients with advanced CKD. In patients with ...
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