FDA Drug Approvals Slowed in Q3 as Missed Deadlines and CRLs Rose

Overview

• An RBC Capital Markets analysis found the FDA’s approval rate fell to 73% in Q3 2025, with complete response letters at 15% and missed PDUFA action dates at 11%, versus roughly 87%, 0–10%, and 4% previously.
• RBC linked the deterioration to staffing shortfalls, leadership turnover and inspection backlogs that may have been worsened by the government shutdown, noting the report reflects external analysis rather than an FDA statement.
• Manufacturing and facility problems accounted for about 40% of 2025 CRLs, up from roughly 29% in 2024, with several letters tied to Novo Nordisk’s Indiana plant affecting companies including Regeneron and Scholar Rock.
• Most delays were traced to CDER and were concentrated in biologics and new molecular entities, while the report still characterized overall decision permissiveness as fair.
• Hematology and endocrine submissions saw the most timing setbacks, and RBC cautioned that upcoming PDUFA dates for BioCryst, Regeneron, Cytokinetics, Arrowhead and Agios could slip if current trends continue.