Give Kids a Chance Act of 2025

The Give Kids a Chance Act of 2025 modifies FDA regulations to improve pediatric cancer drug development and extends incentives for rare pediatric disease treatments. It requires drug developers seeking approval for molecularly targeted cancer drugs to include pediatric-focused studies (e.g., dosing, safety) for specific cancer types, with new FDA guidance due within 12 months. The bill also extends the rare pediatric disease priority review voucher program through 2029 and mandates a GAO study to evaluate how effectively these vouchers spur development of treatments for rare pediatric diseases, reporting findings by 2034. This directly affects pharmaceutical companies developing cancer drugs and the FDA’s approval process, aiming to accelerate treatments for children with cancer and rare diseases.