> ## Content Index
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# 26 FDA Orphan Drug Approvals in 2024
- URL: https://www.fdaweb.com/26-fda-orphan-drug-approvals-in-2024/
- Published: 2025-05-28T12:00:00.000Z
- Updated: 2026-09-14T15:12:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159261

The CDER Accelerating Rare Disease Cures (ARC) program online newsletter says ARC closed out a strong 2024 for rare disease therapeutic development with 26 novel orphan drug approvals. “Having built a strong foundation, CDER’s ARC program renews our commitment in 2025 to strengthen collaboration, including our commitment to the Rare Disease Innovation Hub, to accomplish even greater progress in rare disease drug development,” it [says](http://www.fdaweb.com/download.php?file=arc%5Fupdate.docx).

The newsletter also describes new Learning and Education to Advance and Empower Rare Disease Drug Developers case studies and videos, and lists four selected orphan drug approvals already this year.