Novel Drug Approvals 2023

Abstract

his article provides an overview of the novel drugs approved for 2023. The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) provides standards to drug developers. The CDER sets standards for required data needed in the drug development and application process. Every year a variety of new drugs and biological products are approved. Some are new molecular compounds while others are structurally similar to those already on the market. Therefore, products may not have been used in medical practice previously while others have already been used in practice. This article highlights medications that are new in medical practice over the last year and bring attention to the numerous advancements in medicine. From January 1, 2023, to December 6, 2023, the FDA has approved fifty-three novel drugs highlighted in Table 1. Hematology and Oncology accounted for the majority of drug approvals. Four medications are discussed in detail based on their use in the outpatient setting.