Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer ...

Original Medicare (Part A and Part B), Part D, and Medicare Advantage typically offer coverage for the osteoporosis drug Prolia. However, individuals must meet certain requirements for Part B coverage ...

--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 ...

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 denosumab-qbde demonstrated comparable quality, efficacy, safety, and immunogenicity to the reference product. Enoby is approved to treat postmenopausal women with osteoporosis at high ...

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 ...

The US Food and Drug Administration (FDA) has added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) about increased risk for severe hypocalcemia in patients with advanced ...

(Reuters) - Amgen Inc, the world's largest biotechnology company, said U.S. health regulators approved its Prolia injection for a new use as a treatment to increase bone mass in men with osteoporosis ...

Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...

Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA ...