{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T23:31:17Z","timestamp":1790379077579,"version":"4.1.0"},"reference-count":8,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T00:00:00Z","timestamp":1756339200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T00:00:00Z","timestamp":1756339200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Mol Diagn Ther"],"published-print":{"date-parts":[[2025,9]]},"DOI":"10.1007\/s40291-025-00804-7","type":"journal-article","created":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T07:53:43Z","timestamp":1756367623000},"page":"701-704","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Prademagene Zamikeracel: First Approval"],"prefix":"10.1007","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6519-7831","authenticated-orcid":false,"given":"Arnold","family":"Lee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,8,28]]},"reference":[{"key":"804_CR1","doi-asserted-by":"publisher","first-page":"933","DOI":"10.2147\/CCID.S232547","volume":"12","author":"S Eichstadt","year":"2019","unstructured":"Eichstadt S, Tang JY, Solis DC, et al. From clinical phenotype to genotypic modelling: incidence and prevalence of recessive dystrophic epidermolysis bullosa (RDEB). Clin Cosmet Investig Dermatol. 2019;12:933\u201342.","journal-title":"Clin Cosmet Investig Dermatol"},{"key":"804_CR2","unstructured":"Abeona Therapeutics Inc. US FDA approves ZEVASKYN(TM) (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB) [media release] 29 Apr 2025. https:\/\/investors.abeonatherapeutics.com\/press-releases\/detail\/303\/u-s-fda-approves-zevaskyn-prademagene-zamikeracel."},{"key":"804_CR3","unstructured":"Abeona Therapeutics Inc. Abeona Therapeutics, EB Research Partnership and EB Medical Research Foundation to collaborate on epidermolysis bullosa (EB) treatments [media release] 9 Aug 2016. http:\/\/www.abeonatherapeutics.com."},{"key":"804_CR4","unstructured":"Abeona Therapeutics Inc. ZEVASKYN (prademagene zamikeracel), gene-modified cellular sheets, for topical use: US prescribing information. 2025."},{"issue":"19","key":"804_CR5","doi-asserted-by":"publisher","DOI":"10.1172\/jci.insight.130554","volume":"4","author":"S Eichstadt","year":"2019","unstructured":"Eichstadt S, Barriga M, Ponakala A, et al. Phase 1\/2a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa. JCI Insight. 2019;4(19): e130554.","journal-title":"JCI Insight."},{"issue":"5","key":"804_CR6","doi-asserted-by":"publisher","first-page":"S138","DOI":"10.1016\/j.jid.2023.03.816","volume":"143","author":"JY Tang","year":"2023","unstructured":"Tang JY, Marinkovich MP, Wiss K, et al. Results from VIITAL: a phase 3, randomized, intrapatient-controlled trial of an investigational collagen type VII gene\u2013corrected autologous cell therapy, EB-101, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). J Investig Dermatol. 2023;143(5):S138.","journal-title":"J Investig Dermatol"},{"issue":"377","key":"804_CR7","first-page":"1","volume":"17","author":"JY So","year":"2022","unstructured":"So JY, Nazaroff J, Iwummadu CV, et al. Long-term safety and efficacy of gene-corrected autologous keratinocyte grafts for recessive dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2022;17(377):1\u201313.","journal-title":"Orphanet J Rare Dis"},{"key":"804_CR8","unstructured":"US Food and Drug Administration. BLA approval letter for prademagene zamikeracel. 2025. https:\/\/www.fda.gov. Accessed 7 Jul 2025."}],"container-title":["Molecular Diagnosis &amp; Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40291-025-00804-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40291-025-00804-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40291-025-00804-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,15]],"date-time":"2025-09-15T20:02:52Z","timestamp":1757966572000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40291-025-00804-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,28]]},"references-count":8,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["804"],"URL":"https:\/\/doi.org\/10.1007\/s40291-025-00804-7","relation":{},"ISSN":["1177-1062","1179-2000"],"issn-type":[{"value":"1177-1062","type":"print"},{"value":"1179-2000","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,28]]},"assertion":[{"value":"13 July 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 August 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Arnold Lee is a contracted employee of Adis International Ltd\/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability"}}]}}