Recent and anticipated novel drug approvals for 2024.

Publisher: Oxford University Press Country of Publication: England NLM ID: 9503023 Publication Model: Print Cited Medium: Internet ISSN: 1535-2900 (Electronic) Linking ISSN: 10792082 NLM ISO Abbreviation: Am J Health Syst Pharm Subsets: MEDLINE

Publication: <2019-> : [Oxford] : Oxford University Press
Original Publication: Bethesda, MD : The Society, c1995-

Drug Approval* ; United States Food and Drug Administration*; Humans ; United States ; Pharmacists/organization & administration ; Antineoplastic Agents/therapeutic use

Purpose: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing periodic updates on new and anticipated novel drug approvals.
Summary: Selected drug approvals anticipated in the 12-month period covering the first quarter of 2024 through the fourth quarter of 2024 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 59 novel drugs awaiting US Food and Drug Administration approval. This year's pipeline includes recently added drugs with various indications including oncology, infectious diseases, genetic disorders, and rare diseases. New cellular and gene therapies are rapidly evolving and being studied for several rare diseases and cancers.
Conclusion: More oncology agents, including gene therapies, oral agents, and monoclonal antibodies, are in the pipeline this year. Additional diseases targeted by new novel drugs, including cellular and gene therapies, are hemophilia, nonalcoholic steatohepatitis, Alzheimer's disease, and rare diseases such as galactosemia and epidermolysis bullosa.
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Keywords: Food and Drug Administration drug approval; clinical trials; drug approval process; investigational drugs; medication development; new drug approvals

0 (Antineoplastic Agents)

Date Created: 20240219 Date Completed: 20240507 Latest Revision: 20240507

20240507

10.1093/ajhp/zxae046

38373160