Prolia (Denosumab) FDA Approval History
A detailed regulatory timeline of denosumab (Prolia/Xgeva) from initial FDA approval through post-market safety updates, label expansions, and biosimilar developments.
Denosumab: Regulatory History
5 source-based articles maintained by the HealthRX.com Editorial Team.
5articles
3topic areas covered
May 27, 2026latest review
Denosumab: Regulatory History library
Showing 5 of 5 clinical reviews.
Prolia (Denosumab) Global Regulatory Status: FDA Approval, Label Updates, and Post-Market Safety
Complete regulatory overview of denosumab (Prolia/Xgeva) covering FDA approval history, EMA authorization, boxed warning additions, REMS requirements, and global post-market surveillance findings.
Prolia (Denosumab) Label Updates 2020 to 2026: FDA Safety Changes, Boxed Warnings, and Post-Market Data
The FDA Prolia (denosumab) label, last revised March 2025, warns that stopping treatment raises fracture risk, including multiple vertebral fractures.
Prolia (Denosumab): EMA vs FDA Regulatory Approaches Compared
A side-by-side comparison of how the FDA and EMA regulate denosumab (Prolia/Xgeva), including approval timelines, label differences, post-market safety signals, and discontinuation guidance.
Prolia (Denosumab): FDA Pipeline, Label Updates, and Next-Generation Developments
Current 2026 review of the Prolia FDA label, severe hypocalcemia boxed warning, discontinuation risk, approved denosumab biosimilars, and treatment planning.