Biologic medicines drove innovation in 2023, contributing an outsize share of products qualifying for the US FDA’s expedited review programs compared with new molecular entities.
Biologics Overshadow Small Molecules In US FDA’s 2023 Novel Approvals
Gene therapies, bispecific antibodies and vaccines stand out among 2023’s 34 novel biologics and the US FDA’s 38 new molecular entities include fewer breakthroughs.

More from Approvals
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.