← FDA DRUG APPROVALS

FDA BLA · BLA761107

GAMIFANT

emapalumab-lzsg

Sponsor: NOVIMMUNE S.A.

APPLICATION
BLA761107
TYPE
BLA
ORIGINAL APPROVAL
2018-11-20
LATEST ACTION
2026-03-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GAMIFANTPrescription
EMAPALUMAB-LZSG 100MG/20ML · INJECTABLE · INJECTION
GAMIFANTPrescription
EMAPALUMAB-LZSG 10MG/2ML · INJECTABLE · INJECTION
GAMIFANTPrescription
EMAPALUMAB-LZSG 50MG/10ML · INJECTABLE · INJECTION

Approval history

2026-03-17Labeling · Supplement 22 · standard — Letter ↗AP
2025-06-27Efficacy · Supplement 18 · priority — Letter ↗AP
2020-06-26Manufacturing (CMC) · Supplement 4AP
2018-11-20Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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.

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