Renal & Urology News20h
Denosumab Biosimilar Stoboclo, Osenvelt Get FDA Approval
The FDA has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt (denosumab-bmwo), a biosimilar to Xgeva (denosumab).
Pharmabiz6h
US FDA approves Celltrion’s Stoboclo and Osenvelt biosimilars referencing Prolia and Xgeva
US FDA approves Celltrion’s Stoboclo and Osenvelt biosimilars referencing Prolia and Xgeva: Jersey City, New Jersey Wednesday, March 5, 2025, 18:00 Hrs [IST] Celltrion, a leadin ...
Drug Store News4h
Celltrion receives FDA nod for Prolia, Xgeva biosimilars
Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt ...
Managed Healthcare Executive21h
FDA Approves Prolia and Xgeva Biosimilars, Stoboclo and Osenvelt
Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.
Targeted Oncology23h
Two Denosumab Biosimilars Pocket FDA Approval in Multiple Indications
The FDA has approved 2 biosimilars, denosumab-bmwo (CT-P41; Stoboclo) and (Osenvelt), for all indications of their respective reference products (Prolia) and (Xgeva), Celtrion stated in a news release ...
Managed Healthcare Executive21h
FDA Accepts Amneal’s BLA for Two Denosumab Biosimilars
The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.
Hosted on MSN20h
Compounders Sue FDA; Young Women in Perimenopause; More Osteoporosis Biosimilars
A significant number of women ages 30 to 45 said they experience perimenopause-related symptoms, according to a study with 4,432 U.S. participants. (npj Women's Health) The CDC will stop processing ...