Alert detail

FDA Approval: MIMRYLO (RUSFERTIDE ACETATE) — Type 1 - New Molecular Entity

Policy ID: FDA-NDA220605Specialty: HematologyAdded: 9/3/2026Effective: August 28, 2026federal register

Routine

What changed

Orphan NME approved; billing pathway TBD pending FDA label.

Who’s affected: Hematology billing teams · Effective: August 28, 2026

Primary source: View the official CMS/MAC document ↗

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