Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2026-02-13

FDA Approved: RYBREVANT FASPRO — Original Application (Janssen Biotech, Inc.)

View source ↗

Summary

FDA approved the original biologics license for Rybrevant Faspro, a subcutaneous formulation of amivantamab with hyaluronidase-lpuj, developed by Janssen Biotec…

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

Diseases / indications

Drugs mentioned

  • RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj (human recombinant))

Snippet

ORIG AP for RYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT))