Year: 2026
Type: article
Abstract: 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.KEYWORDS: Drug approval, drug labeling, drug therapy 미국 식품의약국(Food and Drug Administration, FDA) 의약 품 평가 연구 센터(Center for Drug Evaluation and Research, CDER)는 CDER에서 허가한 의약품 중에서 이전에 없었던 새 로운 분자 구조의 화합물(new molecular entity, NME), 이전에 없었던 계열(효능군 또는 작용기전)의 새로운 약(first-in-class), 미충족 의료 수요(unmet medical needs)에 부합하는 신약 등을 "혁신신약(novel drug)"이라는 이름으로 매년 발표한다.이 혁신 신약 목록에는 신약 허가 신청(New Drug Applications, NDA) 절차에 따라 허가를 받은 NME와 생물의약품 허가 신청(Biologics License Applications, BLA)
Author: Young Sook Lee
Institution: Keimyung University
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W7140184859
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