2025 FDA approvals: Innovation holds steady in first year under new leadership

It was a year of leadership turnover and staffing shortages at FDA, but those challenges weren’t reflected in the 2025 class of new drug approvals. Instead, continuity emerged as the defining theme, and the year delivered some important approvals. 

BioCentury’s analysis of the innovativeness of therapeutics approved by FDA in 2025 finds consistency with 2024 across all metrics. First-in-class approvals were flat year over year, whether defined by novel targets, new modalities, or first-in-indication status...