On Dec 19, 2025, the US Food and Drug Administration (FDA) announced a major milestone by qualifying total hip bone mineral density (BMD), assessed by dual-energy X-ray absorptiometry, as a surrogate ...
Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan. Denosumab, used in osteoporosis ...
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 ...
CVS Caremark will begin offering osteoporosis biosimilars Ospomyv and Stoboclo, as well as generic teriparatide, Bonsity and ...
Dr. Reddy’s and Alvotech shared that the Food and Drug Administration has accepted a 351(k) Biologic License Application submission for AVT03, which was developed by Alvotech, and is a proposed ...
Researchers at Pompeu Fabra University (UPF) have made a great leap toward predicting the risk of hip fracture among people with osteoporosis and evaluating the effectiveness of specific drugs to ...
(Corrects paragraph 5 in February 5 story to say 2025 Prolia sales were $4.4 billion, not $1.05 billion) Feb 5 (Reuters) - ...
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 ...
Denosumab (Prolia) is a leading treatment for osteoporosis, but the rapid bone loss that can occur after discontinuing the RANK ligand inhibitor can be challenging to navigate. "I don't think we have ...