Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-06-27

FDA Approved: GAMIFANT — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

View source ↗

Summary

The FDA approved a supplemental application for GAMIFANT (emapalumab-lzsg) filed by Swedish Orphan Biovitrum AB (publ). The action updates the drug’s labeling f…

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

Diseases / indications

Drugs mentioned

  • GAMIFANT (emapalumab-lzsg)

Snippet

SUPPL AP for GAMIFANT (EMAPALUMAB-LZSG)