Pink SheetRare and pediatric disease drug sponsors and the US Food and Drug Administration could resolve several ongoing rare and pediatric drug development issues in a compromise bill to fund the government th
Pink SheetLegal challenges of US Food and Drug Administration exclusivity determinations are among the early cases where the Supreme Court’s overturning of the Chevron doctrine of deference is being cited. Th
Pink SheetRare diseases are almost certain to remain one of the biggest areas for novel drug development in 2024, but the orphan drug pipeline will be making space for some novel therapies for common conditions
Pink SheetAll of the six novel agents with April 2024 user fee goal dates at the US FDA are using an expedited review pathway, the Pink Sheet FDA Performance Tracker’s User Fee Goal Dates tracker shows: fou