The U.S. Food and Drug Administration (FDA) has released the 2025 Accelerating Rare disease Cures (ARC) Program Annual Report.
Since its launch in 2022, the Center for Drug Evaluation and Research (CDER) ARC Program continues to be a key resource for the rare disease community and a driver of innovative approaches for rare disease drug development. The ARC Program is dedicated to driving scientific and regulatory innovation and engagement while closing the gap between the challenges of developing drugs for rare diseases and the urgent need for treatment options for patients.