The FDA has declined approval for Disc Medicine's rare disease therapy, which was previously associated with the commissioner's voucher program. The rejection marks a setback for the company's efforts to bring the treatment to market.
The Consolidated Appropriations Act, 2026 extends the FDA’s rare pediatric disease priority review voucher authority through Sept. 30, 2029. The law also requires a GAO report on the program’s effectiveness.
The Consolidated Appropriations Act of 2026 extends the FDA's authority to award rare pediatric disease priority review vouchers through September 30, 2029, restoring a key incentive for developing therapies for rare pediatric diseases.
