Expediting Treatments in the 21st Century: Orphan Drugs and Accelerated Approvals January 22, 2025 Share this page The typical timings for AA to be confirmed or withdrawn has not changed significantly over the decades, the disease areas utilizing orphan drug designation and AA have changed significantly over time. Accelerated Approval Orphan Drug Incentives Related Articles FDA Takes Important Step Toward Individualized Therapies February 24, 2026 Congress Passes Five-Year Reauthorization of Rare Pediatric Disease PRV Program February 03, 2026 The Government Reopens November 13, 2025 See All News