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 ...

Prolia should be covered by Medicare Part A, Part B, or Part D, depending on why you need to take the drug and whether you will administer it yourself. Prolia (denosumab) is an injectable monoclonal ...

Prolia (denosumab) is a medication for osteoporosis. A healthcare professional administers Prolia via injection under the skin every 6 months. Medicare covers Prolia for beneficiaries. Since a ...

Dr. Reddy’s and Alvotech have entered into a license and supply agreement for the commercialization of AVT03, Alvotech’s biosimilar candidate to Prolia and Xgeva (denosumab). The collaboration ...

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 ...

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 ...

Please provide your email address to receive an email when new articles are posted on . The FDA is investigating the risk of severe hypocalcemia in patients on dialysis treated with the osteoporosis ...