← FDA DRUG APPROVALS

FDA BLA · BLA761210

RYBREVANT

amivantamab-vmjw

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761210
TYPE
BLA
ORIGINAL APPROVAL
2021-05-21
LATEST ACTION
2025-11-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RYBREVANTPrescription
AMIVANTAMAB-VMJW 350MG/7ML(50MG/ML) · INJECTABLE · INJECTION

Approval history

2025-11-07Labeling · Supplement 11 · standard — Letter ↗AP
2025-10-08Labeling · Supplement 10 · standard — Letter ↗AP
2025-09-03Labeling · Supplement 8 · standard — Letter ↗AP
2025-08-14Efficacy · Supplement 9 · standard — Label ↗AP
2025-02-14Labeling · Supplement 7 · standard — Letter ↗AP
2024-09-19Efficacy · Supplement 4 · standard — Letter ↗AP
2024-08-19Efficacy · Supplement 5 · priority — Letter ↗AP
2024-03-01Efficacy · Supplement 3 · priority — Label ↗AP
2022-11-04Efficacy · Supplement 2 · standard — Label ↗AP
2021-12-21Labeling · Supplement 1 · standard — Letter ↗AP
2021-05-21Type 1 - New Molecular Entity · Original · priority — Label ↗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 →