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FDA Approves 61 New Drugs in 2024, Including 19 with Big Clinical Impact and 21% Complete Response Letters

Jan 2, 2025, 02:57 PM

In 2024, the U.S. Food and Drug Administration (FDA) granted 61 novel approvals for new molecular entities and biologics, marking a notable achievement in drug development. This figure places 2024 behind only 2023 and 2018 for the highest number of approvals in a single year. According to GoodRx, 19 of these approvals had a 'big clinical impact.' However, 21% of applications received a complete response letter, indicating some challenges in the approval process. The trend highlights the increasing role of small companies in the pharmaceutical sector, as several key approvals came from these entities.