← FDA DRUG APPROVALS

FDA BLA · BLA761320

LYTENAVA

Sponsor: OUTLOOK THERAPEUTICS, INC.

APPLICATION
BLA761320
TYPE
BLA
ORIGINAL APPROVAL
2026-07-24
LATEST ACTION
2026-07-24
ROUTE
SINGLE-DOSE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

LYTENAVAPrescription
BEVACIZUMAB-VIKG 1.25MG (0.05ML of 25MG/ML · VIAL · SINGLE-DOSE

Approval history

2026-07-24Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industryGMP disciplineFDA drug shortagesFDA 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 →