Alert detail

FDA Approval: LYNOZYFIC (LINVOSELTAMAB-GCPT) — Type 1 - New Molecular Entity

Policy ID: FDA-BLA761400Specialty: HematologyAdded: 8/5/2026Effective: July 2, 2025billing update
Critical

What changed

New injectable orphan biologic; watch for J-code assignment.

Who’s affected: Hematology billing teams · Effective: July 2, 2025

Primary source: View the official CMS/MAC document ↗

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FDA Approval: LYNOZYFIC (LINVOSELTAMAB-GCPT) — Type 1 - New Molecular Entity