Better Late Than Never? FDA Receives Long-Awaited Statutory Fix for Orphan Drug Exclusivity in Recent Appropriations Act

The Consolidated Appropriations Act, signed into law on February 3, 2026, avoided another government shutdown. But notably for the US Food and Drug Administration (FDA) and drug developers, it also codified FDA’s long-standing approach toward the scope of orphan drug exclusivity that had become a subject of litigation in recent years.... By: Cooley LLP