New FDA Drug Approvals for 2024: Synthesis and Clinical Application

Abstract

In 2024, the U.S. Food and Drug Administration (FDA) has approved a range of new drugs, including both 32 new chemical entities (NCEs) and 18 biological entities (NBEs). Among the approved new drugs, small-molecule chemical drugs remained the main force for innovation, taking a commanding lead with a proportion of 64%, covering targets like LACTB, PBP, THR-β, Raf, PDE3/4, and HIF. Monoclonal antibodies followed with 13 drugs (26%), along with 2 protein-based drugs (4%), 2 small nucleic acid drugs (4%), and 1 parathyroid hormone analogue (2%). The diseases treated by these approved new drugs were diverse, with the total number of new drugs for treating rare diseases and cancers ranking high. Additionally, multiple new drugs were also approved in the fields of anti-infective and central nervous system diseases. Similar to previous years, many of these drugs are likely to undergo accelerated approval processes to address urgent medical needs, particularly for rare diseases. This review provides an overview of the synthesis and clinical applications of NCEs approved by the FDA in 2024. The increasing importance of clinical applications has also been discussed. This review aims to provide valuable insights for the design of future drugs, particularly in the context of rare and complex diseases.