While the fourth quarter of 2024 continued the trend seen throughout the year of increasing momentum in FDA new drug approvals, with 16 such approvals handed out, the first quarter of 2025 has definitely seen that trend bucked. Only seven new drug approvals were awarded by the FDA in Q1 (Table 1), notably lower than in any individual quarter in 2024. By contrast, the commercial expectations for the latest quarter’s approval cohort are much more positive, driven in large part by two potential blockbuster products.
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Competing Interests
The author declares no competing interests.
