After kicking off 2023 with a potential megablockbuster in Eisai and Biogen’s new Alzheimer’s drug Leqembi, in totality the FDA signed off on 10 more novel drug approvals in 2023 when compared to last year.
The 57 novel drugs approved in 2023 (not counting gene therapies or vaccines) are the most since 2018 — the year of Gilead’s blockbuster HIV drug Biktarvy, which generated $10.4 billion in 2022 sales.
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