{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T01:43:22Z","timestamp":1792806202983,"version":"4.5.0"},"reference-count":7,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T00:00:00Z","timestamp":1706140800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Research Foundation (NRF) and the University of KwaZulu-Natal","id":[{"id":"https:\/\/ror.org\/04qzfn040","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>With the COVID-19 pandemic behind us, the U.S. Food and Drug Administration (FDA) has approved 55 new drugs in 2023, a figure consistent with the number authorized in the last five years (53 per year on average). Thus, 2023 marks the second-best yearly FDA harvest after 2018 (59 approvals) in all the series. Monoclonal antibodies (mAbs) continue to be the class of drugs with the most approvals, with an exceptional 12, a number that makes it the most outstanding year for this class. As in 2022, five proteins\/enzymes have been approved in 2023. However, no antibody\u2013drug conjugates (ADCs) have been released onto the market. With respect to TIDES (peptides and oligonucleotides), 2023 has proved a spectacular year, with a total of nine approvals, corresponding to five peptides and four oligonucleotides. Natural products continue to be the best source of inspiration for drug development, with 10 new products on the market. Three drugs in this year\u2019s harvest are pegylated, which may indicate the return of pegylation as a method to increase the half-lives of drugs after the withdrawal of peginesatide from the market in 2013. Following the trends in recent years, two bispecific drugs have been authorized in 2023. As in the preceding years, fluorine and\/or N-aromatic heterocycles are present in most of the drugs. Herein, the 55 new drugs approved by the FDA in 2023 are analyzed exclusively on the basis of their chemical structure. They are classified as the following: biologics (antibodies, proteins\/enzymes); TIDES (peptide and oligonucleotides); combined drugs; pegylated drugs; natural products; nitrogen aromatic heterocycles; fluorine-containing molecules; and other small molecules.<\/jats:p>","DOI":"10.3390\/molecules29030585","type":"journal-article","created":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T06:54:12Z","timestamp":1706165652000},"page":"585","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":107,"title":["The Pharmaceutical Industry in 2023: An Analysis of FDA Drug Approvals from the Perspective of Molecules"],"prefix":"10.3390","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8521-9172","authenticated-orcid":false,"given":"Beatriz G.","family":"de la Torre","sequence":"first","affiliation":[{"name":"Kwazulu-Natal Research Innovation and Sequencing Platform (KRISP), College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8946-0462","authenticated-orcid":false,"given":"Fernando","family":"Albericio","sequence":"additional","affiliation":[{"name":"School of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South Africa"},{"name":"Department of Organic Chemistry, University of Barcelona, 08028 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,1,25]]},"reference":[{"key":"ref_1","unstructured":"U.S. Food and Drug Administration (FDA) (2024, January 01). Available online: https:\/\/www.fda.gov\/drugs\/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products\/novel-drug-approvals-2023."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"de la Torre, B.G., and Albericio, F. (2023). The Pharmaceutical Industry in 2022. An Analysis of FDA Drug Approvals from the Perspective of Molecules; and other articles of the same series. Molecules, 28.","DOI":"10.3390\/molecules28031038"},{"key":"ref_3","unstructured":"U.S. Food and Drug Administration (FDA) (2024, January 01). Available online: https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products."},{"key":"ref_4","unstructured":"U.S. Food and Drug Administration (FDA) (2024, January 01). Available online: https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/2023-biological-license-application-approvals."},{"key":"ref_5","unstructured":"(2024, January 01). Reata Pharmaceuticals has Been Acquired by Biogen. Available online: https:\/\/www.reatapharma.com\/investors\/news\/news-details\/2022\/Reata-Pharmaceuticals-Announces-FDA-Filing-Acceptance-and-Priority-Review-Designation-for-the-NDA-for-Omaveloxolone-for-the-Treatment-of-Patients-with-Friedreichs-Ataxia\/default.aspx."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"961","DOI":"10.1111\/dom.14940","article-title":"Tirzepatide versus semaglutide for weight loss in patients with type 2 diabetes mellitus: A value for money analysis","volume":"25","author":"Azuri","year":"2023","journal-title":"Diabetes Obes. Metab."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"de la Torre, B.G., and Albericio, F. (2022). The Pharmaceutical Industry in 2022. An Analysis of FDA Drug Approvals from the Perspective of Molecules. Molecules, 27.","DOI":"10.3390\/molecules27031075"}],"container-title":["Molecules"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1420-3049\/29\/3\/585\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T13:48:54Z","timestamp":1760104134000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1420-3049\/29\/3\/585"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,25]]},"references-count":7,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,2]]}},"alternative-id":["molecules29030585"],"URL":"https:\/\/doi.org\/10.3390\/molecules29030585","relation":{},"ISSN":["1420-3049"],"issn-type":[{"value":"1420-3049","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,25]]}}}