US FDA Novel Drug Approval for 2024.

SPECIAL REPORT 25.1

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US FDA Novel Drug Approval for 2024.The latest report issued by the FDA’s Center for Drug Evaluation and Research (CDER) indicates that the US health agency has approved 50 novel drugs in 2024. The full list of the new drugs, their commercial names and their therapeutic indications can be found below (1)

The 2024 CDER approvals were slightly inferior to the ones of 2023 when the US FDA had granted 55 new marketing authorisations, but significantly higher than the ones of 2022 with a low of 37 new entities registered.

Contrary to a common and wrong perception, every year small molecules (SMEs) represent the majority of the US FDA approvals. In 2024, 27 out of the 50 approved drugs were SMEs and 13 monoclonal antibodies got a marketing authorisation (12 in 2023).

Geographic distribution of the various sponsors is also of interest: 28 originated from the US, 15 from Europe (2 from France: Ipsen and Servier) and 7 from the Asia-Pacific region (Japan 3, India 2, China 1, Australia 1).

It is also worth noticing that only 21 out of the 50 approvals were granted to large of well-established biopharmaceutical companies, showing a recent new trend where emerging biotechnology companies develop a strategy to file by themselves in the US in order to maximise the value of their assets.

^{This document has been prepared by Jean-Claude Muller and is provided for information purposes only. The information contained herein has been obtained from sources believed to be reliable but is not warranted to be accurate or complete. The views presented are those of the author at the time of writing and are subject to change. Jean-Claude Muller has no obligation to update these opinions or the information presented.}