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FDA BLA · BLA761211

LOARGYS

pegzilarginase-nbln

Sponsor: IMMEDICA PHARMA AB

APPLICATION
BLA761211
TYPE
BLA
ORIGINAL APPROVAL
2026-02-23
LATEST ACTION
2026-02-23
ROUTE
INTRAVENOUS, SUBCUTANEOUS, Injection
DOSAGE FORM
Injectable
MARKETING STATUS
Prescription

Products

LOARGYSPrescription
PEGZILARGINASE-NBLN 0.1MG/KG · Injectable · Injection

Approval history

2026-02-23Type 1 - New Molecular Entity · Original · priorityLetterAP
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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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