So far in 2025, from January through November, 39 novel drugs have been approved in the U.S., just short of the 43 approvals seen during the same period last year.Over the full year of 2024, the FDA approved 50 novel drugs, matching the total from 2021 and making it the fourth-highest approval year. The highest number of novel drug approvals occurred in 2018, with 59, followed by 55 in 2023 and 53 in 2020.