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FDA Medical Review – ENHERTU SUPPL‑28 for Adult HER2‑Positive Solid Tumors (Approved April 5, 2024)
FDA Medical Review – ENHERTU SUPPL‑28 for Adult HER2‑Positive Solid Tumors (Approved April 5, 2024)
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Original Request Contents: Medical review and cross-discipline team reviews for ENHERTU SUPPL-28, approved April 5, 2024, for adult HER2-positive solid tumors
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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