{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T10:35:10Z","timestamp":1790850910543,"version":"4.1.0"},"reference-count":54,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T00:00:00Z","timestamp":1767139200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>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 updates on new and anticipated novel drug approvals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Summary<\/jats:title>\n                    <jats:p>Selected drug approvals anticipated in the 12-month period covering the fourth quarter of 2025 through the third quarter of 2026 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 41 novel drugs awaiting US Food and Drug Administration approval. This year\u2019s pipeline features novel therapies for various disease states, including rare diseases, Wiskott-Aldrich syndrome, and mucopolysaccharidosis type II, as well as targeted cancer treatments and cell and gene therapies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Novel therapies continue to strengthen the current drug pipeline.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ajhp\/zxaf338","type":"journal-article","created":{"date-parts":[[2025,12,20]],"date-time":"2025-12-20T12:53:48Z","timestamp":1766235228000},"page":"303-311","source":"Crossref","is-referenced-by-count":6,"title":["Recent and anticipated novel drug approvals (4Q 2025 through 3Q 2026)"],"prefix":"10.1093","volume":"83","author":[{"given":"Brittany L","family":"Karas","sequence":"first","affiliation":[{"name":"Northwestern Medicine , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Golf","sequence":"additional","affiliation":[{"name":"Northwestern Medicine , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Shepard","sequence":"additional","affiliation":[{"name":"Northwestern Medicine , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Cherry","sequence":"additional","affiliation":[{"name":"Northwestern Medicine , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew M","family":"Levitsky","sequence":"additional","affiliation":[{"name":"IPD Analytics , Aventura, FL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew H","family":"Rim","sequence":"additional","affiliation":[{"name":"Northwestern Medicine , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,12,31]]},"reference":[{"key":"2026030907330865500_zxaf338-B1","author":"Brand and Biosimilar Pipeline Database [proprietary data]"},{"key":"2026030907330865500_zxaf338-B2","doi-asserted-by":"publisher","DOI":"10.1093\/ajhp\/zxaf237","article-title":"Recent and anticipated novel drug approvals (3Q 2025 through 2Q 2026)","author":"Rim","journal-title":"Am J Health-Syst Pharm"},{"issue":"19","key":"2026030907330865500_zxaf338-B3","doi-asserted-by":"publisher","first-page":"e805","DOI":"10.1093\/ajhp\/zxaf147","article-title":"Recent and anticipated novel drug approvals (2Q 2025 through 1Q 2026)","volume":"82","author":"Rim","year":"2025","journal-title":"Am J Health-Syst Pharm"},{"issue":"13","key":"2026030907330865500_zxaf338-B4","doi-asserted-by":"publisher","first-page":"e600","DOI":"10.1093\/ajhp\/zxaf030","article-title":"Recent and anticipated novel drug approvals (1Q 2025 through 4Q 2025)","volume":"82","author":"Rim","year":"2025","journal-title":"Am J Health-Syst Pharm"},{"key":"2026030907330865500_zxaf338-B5","author":"US Food and Drug Administration"},{"key":"2026030907330865500_zxaf338-B6","author":"Fondazione Telethon"},{"key":"2026030907330865500_zxaf338-B7","author":"Atara Biotherapeutics"},{"issue":"suppl 1","key":"2026030907330865500_zxaf338-B8","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1182\/blood-2024-198159","article-title":"Updated clinical results: a multicenter, open-label, phase 3 study of tabelecleucel for solid organ or allogeneic hematopoietic cell transplant recipients with Epstein-Barr virus-driven post transplant lymphoproliferative disease after failure of rituximab or rituximab plus chemotherapy","volume":"144","author":"Ghobadi","year":"2024","journal-title":"Blood"},{"key":"2026030907330865500_zxaf338-B9","author":"Regenxbio"},{"key":"2026030907330865500_zxaf338-B10","author":"Regenxbio"},{"key":"2026030907330865500_zxaf338-B11","author":"Denali Therapeutics announces FDA acceptance and priority review of biologics license application (BLA) for tividenofusp alfa for Hunter syndrome (MPS II)"},{"key":"2026030907330865500_zxaf338-B12","author":"US Food and Drug Administration"},{"key":"2026030907330865500_zxaf338-B13","author":"US Food and Drug Administration"},{"key":"2026030907330865500_zxaf338-B14","author":"US Food and Drug Administration"},{"key":"2026030907330865500_zxaf338-B15","author":"GlaxoSmithKline"},{"key":"2026030907330865500_zxaf338-B16","author":"Serani"},{"key":"2026030907330865500_zxaf338-B17","author":"AstraZeneca"},{"key":"2026030907330865500_zxaf338-B18","author":"Johnson & Johnson"},{"key":"2026030907330865500_zxaf338-B19","author":"Bayer"},{"key":"2026030907330865500_zxaf338-B20","author":"Polaris Group"},{"key":"2026030907330865500_zxaf338-B21","author":"Corcept Therapeutics"},{"key":"2026030907330865500_zxaf338-B22","author":"Kura Oncology"},{"key":"2026030907330865500_zxaf338-B23","author":"Sanofi"},{"issue":"24","key":"2026030907330865500_zxaf338-B24","doi-asserted-by":"publisher","first-page":"2914","DOI":"10.1182\/blood.2024027336","article-title":"Safety and efficacy of rilzabrutinib vs placebo in adults with immune thrombocytopenia: the phase 3 LUNA3 study","volume":"145","author":"Kuter","year":"2025","journal-title":"Blood"},{"key":"2026030907330865500_zxaf338-B25","author":"Insmed"},{"key":"2026030907330865500_zxaf338-B26","author":"Boehringer Ingelheim. U.S"},{"key":"2026030907330865500_zxaf338-B27","author":"US Food & Drug Administration"},{"key":"2026030907330865500_zxaf338-B28","author":"KalVista Pharmaceuticals announces FDA approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema"},{"issue":"1","key":"2026030907330865500_zxaf338-B29","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1056\/NEJMoa2314192","article-title":"Oral sebetralstat for on-demand treatment of hereditary angioedema attacks","volume":"391","author":"Riedl","year":"2024","journal-title":"N Engl J Med"},{"key":"2026030907330865500_zxaf338-B30","author":"Ionis"},{"issue":"1","key":"2026030907330865500_zxaf338-B31","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1056\/NEJMoa2402478","article-title":"Efficacy and safety of donidalorsen for hereditary angioedema","volume":"391","author":"Riedl","year":"2024","journal-title":"N Engl J Med"},{"key":"2026030907330865500_zxaf338-B32","author":"National Eczema Association"},{"key":"2026030907330865500_zxaf338-B33","author":"Leqembi Iqlik"},{"key":"2026030907330865500_zxaf338-B34","author":"Saol Therapeutics"},{"key":"2026030907330865500_zxaf338-B35","author":"PTC Therapeutics"},{"key":"2026030907330865500_zxaf338-B36","author":"ScholarRock"},{"key":"2026030907330865500_zxaf338-B37","author":"Bonavitacola"},{"key":"2026030907330865500_zxaf338-B38","author":"Sentynl Therapeutics, Inc"},{"key":"2026030907330865500_zxaf338-B39","author":"GalxoSmithKline"},{"issue":"24","key":"2026030907330865500_zxaf338-B40","doi-asserted-by":"publisher","first-page":"2337","DOI":"10.1056\/NEJMoa2406673","article-title":"Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype","volume":"391","author":"Jackson","year":"2024","journal-title":"N Engl J Med"},{"issue":"10482","key":"2026030907330865500_zxaf338-B41","doi-asserted-by":"publisher","first-page":"911","DOI":"10.1016\/S0140-6736(25)00197-7","article-title":"Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials","volume":"405","author":"Gevaert","year":"2025","journal-title":"Lancet"},{"key":"2026030907330865500_zxaf338-B42","author":"Waldron"},{"key":"2026030907330865500_zxaf338-B43","author":"Omeros"},{"key":"2026030907330865500_zxaf338-B44","author":"Otsuka Pharmaceuticals"},{"key":"2026030907330865500_zxaf338-B45","author":"Sanofi"},{"issue":"19","key":"2026030907330865500_zxaf338-B46","doi-asserted-by":"publisher","first-page":"1893","DOI":"10.1056\/NEJMoa2415985","article-title":"Tolebrutinib versus teriflunomide in relapsing multiple sclerosis","volume":"392","author":"Oh","year":"2025","journal-title":"N Engl J Med"},{"issue":"19","key":"2026030907330865500_zxaf338-B47","doi-asserted-by":"publisher","first-page":"1883","DOI":"10.1056\/NEJMoa2415988","article-title":"Tolebrutinib in nonrelapsing secondary progressive multiple sclerosis","volume":"392","author":"Fox","year":"2025","journal-title":"N Engl J Med"},{"key":"2026030907330865500_zxaf338-B48","author":"Milestone Pharmaceuticals"},{"key":"2026030907330865500_zxaf338-B49","author":"GlaxoSmithKline"},{"key":"2026030907330865500_zxaf338-B50","author":"Ascendis Pharma"},{"key":"2026030907330865500_zxaf338-B51","author":"Merck"},{"key":"2026030907330865500_zxaf338-B52","author":"American Pharmaceutical Review"},{"key":"2026030907330865500_zxaf338-B53","author":"Shionogi"},{"key":"2026030907330865500_zxaf338-B54","author":"Innoviva Specialty Therapeutics."}],"container-title":["American Journal of Health-System Pharmacy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ajhp\/advance-article-pdf\/doi\/10.1093\/ajhp\/zxaf338\/66169284\/zxaf338.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajhp\/article-pdf\/83\/6\/303\/66169284\/zxaf338.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajhp\/article-pdf\/83\/6\/303\/66169284\/zxaf338.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T11:33:14Z","timestamp":1773055994000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ajhp\/article\/83\/6\/303\/8407583"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,31]]},"references-count":54,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2025,12,31]]},"published-print":{"date-parts":[[2026,3,9]]}},"URL":"https:\/\/doi.org\/10.1093\/ajhp\/zxaf338","relation":{},"ISSN":["1079-2082","1535-2900"],"issn-type":[{"value":"1079-2082","type":"print"},{"value":"1535-2900","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,3,15]]},"published":{"date-parts":[[2025,12,31]]}}}