Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)

New biologicPriority review

Region: 🇺🇸 US
Active substance: amivantamab and hyaluronidase-lpuj
Company: Janssen Biotech
Status: Approved
FDA approval: Wed 17 Dec 2025
Designations: New biologic, Priority review
Application: BLA761433
Official record: www.accessdata.fda.gov

Regulatory milestones

Fri 13 Feb 2026🇺🇸 FDA approval

FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), a new medicine

Janssen Biotech; BLA761484; New biologic; vial · source

Wed 17 Dec 2025🇺🇸 FDA approval

FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), a new medicine

Janssen Biotech; BLA761433; New biologic, Priority review; injection · source

Same substance in other markets

🇺🇸 Rybrevant Faspro Approved · Janssen Biotech

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.