Pharmacological Insights on USFDA-Approved Novel Drug Therapies in the Year 2023.

Abstract

Objective: This manuscript, aimed to prepare a scientific report, underscores the pharma-cotherapeutic aspects, including therapeutic indications, mechanisms of therapeutic action, pharma-cokinetics, adverse reactions, safety in special cases, approximate costs, etc., of USFDA-approved novel drugs in the year 2023 and serve as a treasured resource for academia, researchers, patients, and clinicians.

Methods: This comprehensive report was prepared by reviewing the pre-clinical and clinical data of the USFDA-approved novel drugs available in the public domain, especially on the website of the USFDA, National Library of Medicine, Clinical Trials, other online resources, and cross-references.

Results: The USFDA has approved 55 novel drug therapies in the year 2023 and identified 38 drugs as new chemical entities (29 small molecules, 5 peptides, and 4 oligonucleotides) and 17 new biologics. About 51% (28 out of 55) of drugs were recommended for rare diseases and designated as orphan drugs. In addition to the therapeutic aspects and general description, the approximate cost or price and safety studies in special cases such as lactating and pregnant women, pediatrics, and geriatrics of all novel drug therapies are meticulously presented in the manuscript.

Conclusion: The novel drug therapies approved by the USFDA hold significant potential to enhance the patient's care by providing advanced treatment modalities. This manuscript, reporting the comprehensive description of therapeutic aspects of the mentioned new drug therapies, underscores the commitment of the pharmaceutical sector to address the unmet medical needs and reshape the landscape of the healthcare service system by instilling optimism among patients and healthcare providers.