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 ...
--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 ...
Patients who discontinue treatment with the osteoporosis drug denosumab, despite transitioning to zoledronate, show significant losses in lumbar spine bone mineral density (BMD) within a year, ...
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab ...
SHANGHAI, Sept. 5, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, and Pakistan's The Searle Company Limited (PSX: SEARL, ...
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 ...
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 ...
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