Btobioinnovation.com 

Author: Jean-Claude Muller, Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT 25.1

We wish all our readers and followers a Happy and Prosperous Year 2025

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 through the following link.

https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024

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.

Paris, December 31, 2024.

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.