On Jan. 5, 2018, the U.S. Food and Drug Administration approved the supplemental Biologics License Application for XGEVA to expand the currently approved indication for the prevention of ...

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 ...

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 ...

Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027BRIDGEWATER, ...

Patients with cancer that has metastasized (spread) may benefit from treatment with Xgeva (denosumab), which has been approved by the FDA (Food and Drug Administration) today. Specifically, Xgeva is ...

THOUSAND OAKS, Calif., Nov. 18, 2010 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved ...

Sandoz has obtained the Food and Drug Administration’s clearance for Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the only FDA-approved denosumab biosimilars, to treat all indications of ...

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 ...

THOUSAND OAKS, Calif., Dec. 13, 3010 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced top-line results from a Phase 3 trial evaluating XGEVA ...

Mabxience And Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA®. mAbxience / Key word(s): Miscellaneous mAbxience and Amneal Announces FDA Approval of Denosumab ...