Novel drugs of United States Food and Drug Administration approved in 2024

In 2024, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 50 "novel" drugs, either as new molecular entities under New Drug Applications, or as new therapeutic biologics under Biologics License Applications.These drugs have never been approved or marketed in the U.S.This review presents a focused discussion on selected novel drugs used in disease conditions designated by American College of Clinical Pharmacy (ACCP) pharmacotherapy didactic curriculum toolkit.The discussed novel drugs include: vadadustat for anemia in chronic kidney disease; aprocitentan for refractory hypertension; landiolol for supraventricular tachycardia; deuruxolitinib for alopecia areata; lebrikizumab for atopic dermatitis; donanemab for both mild cognitive impairment and Alzheimer's disease; xanomeline-trospium chloride, an antipsychotic agent for schizophrenia; and ensifentrine as a maintenance therapy for COPD.This review aims to provide essential clinical pharmacology and therapeutic insights to support the pharmacy education and clinical decision-making regarding these newly approved agents.