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Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely

 
• By Bridget Silverman

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

half-way point
CDER’s PERFORMANCE HEADS BACK TO THE MEAN, WHILE CBER STAYS ABOVE AVERAGE. • Source: Shutterstock

The US FDA is unlikely to repeat its 2023 stellar approval performance in 2024, but there is still room for another very good year for new molecular entities and novel biologics, the Pink Sheet US FDA Performance Tracker shows.

Key Takeaways

  • The US FDA approved 27 novel agents in the first half of 2024, behind the torrid approval pace set in 2023 but right on the average since 2016.

  • Almost 40% of candidates with second half 2024 goal dates at the Center for Drug Evaluation and Research’s have breakthrough therapy designations, similar to the first half approvals

The FDA approved 27 novel agents in the first six months of 2024, and then opened the second half with the 2 July approval of Eli Lilly’s Alzheimer’s disease therapy Kisunla (donanemab-azbt)

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