Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-05-30

FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

View source ↗

Summary

The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, authorizing changes to the drug's labeling. This action represents a supp…

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • Prolia (denosumab)

Snippet

SUPPL AP for PROLIA (DENOSUMAB)