Alert detail
FDA Approval: RASONQUE (DARAXONRASIB) — Type 1 - New Molecular Entity
Policy ID: FDA-NDA220910Specialty: OncologyAdded: 9/3/2026Effective: August 26, 2026federal register
What changed
Oral orphan NME daraxonrasib routes to Part D; no J-code applies.
Who’s affected: Oncology billing teams · Effective: August 26, 2026
Primary source: View the official CMS/MAC document ↗
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