2024 FDA Novel Drug Approvals

The agency has approved 55 novel drugs so far, with 47 via CDER and 8 via CBER

Other takeaways:

• This is 22% behind 2023 which saw 71 approvals (16 CBER, 55 CDER) - it's worth noting that the 2023 CDER approval count was the 2nd highest total in 30 years (the peak was 59 in 2018)
• The 47 CDER approvals in 2024 would be in-line with the 10-year historical annual average of 46
• The CDER 10-year rolling average of 46 approvals is the highest it has been in over 20 years and a significant leap from 2010, when it bottomed out at 25
• 2024 saw one of the highest counts of accelerated approvals, although most had active Phase 3 studies at the time of approval, reflecting a reform to the multi-year delays we had seen in previous years
• We saw a few FDA approvals for assets coming out of China, which is a metric worth monitoring as many companies and investors evaluate their BD strategy in the region
• This excludes diagnostics, drugs approved via the 505(b)(2) pathway and source plasma