← FDA DRUG APPROVALS

FDA BLA · BLA761484

RYBREVANT FASPRO

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761484
TYPE
BLA
ORIGINAL APPROVAL
2026-02-13
LATEST ACTION
2026-02-13
ROUTE
SINGLE-USE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

RYBREVANT FASPROPrescription
AMIVANTAMAB AND HYALURONIDASE-LPUJ 2,400MG/30,000 UNITS PER 15ML · VIAL · SINGLE-USE
RYBREVANT FASPROPrescription
AMIVANTAMAB AND HYALURONIDASE-LPUJ 1,600MG/20,000 UNITS PER 10ML · VIAL · SINGLE-USE
RYBREVANT FASPROPrescription
AMIVANTAMAB AND HYALURONIDASE-LPUJ 3,5200MG/44,000 UNITS PER 22ML · VIAL · SINGLE-USE
RYBREVANT FASPROPrescription
AMIVANTAMAB AND HYALURONIDASE-LPUJ 2,240MG/28,000 UNITS PER 14ML · VIAL · SINGLE-USE

Approval history

2026-02-13Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →