Postmenopausal women with osteoporosis who received a regimen of three separate, 6-month cycles of daily teriparatide followed by one subcutaneous injection of denosumab experienced a moderate gain in ...
Based on the results of a non-inferiority study, in January 2018 the U.S. Food and Drug Administration (FDA) approved the use of denosumab for the prevention of skeletal events in patients with ...
Correcting for Discretionary Treatment Crossover in an Analysis of Survival in the Breast International Group BIG 1-98 Trial by Using the Inverse Probability of Censoring Weighted Method Bone ...
THOUSAND OAKS, Calif., June 1 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia ...
Basel, June 2, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, has announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to ...
During the first 12 weeks of treatment, 41.1% of women on denosumab developed severe hypocalcemia compared with 2.0% of those taking oral bisphosphonates, reported a group of largely FDA researchers ...
The US Food and Drug Administration (FDA) has approved denosumab (Prolia, Amgen) for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture, defined as defined ...
INCHEON, Korea, February 15, 2025--(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 ...
Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and ...
Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027BRIDGEWATER, ...
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