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Genetic renaissance: a cross-regional analysis of the approval landscape of authorised gene therapeutics in paediatrics, challenges and future prospects.

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Title: Genetic renaissance: a cross-regional analysis of the approval landscape of authorised gene therapeutics in paediatrics, challenges and future prospects.
Authors: Ahmad A; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India., Simran S; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India., Kalokhe VM; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India., Musthafa F; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India., Gangawane VS; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India., Choudhary KK; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India., Raghuvanshi RS; Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India, Directorate General of Health Services, New Delhi, India., Srivastava S; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India. saurabh@niperhyd.ac.in.; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India. saurabh@niperhyd.ac.in.
Source: Journal of community genetics [J Community Genet] 2025 Oct; Vol. 16 (5), pp. 513-528. Date of Electronic Publication: 2025 May 21.
Publication Type: Journal Article
Journal Info: Publisher: Springer Country of Publication: Germany NLM ID: 101551501 Publication Model: Print-Electronic Cited Medium: Print ISSN: 1868-310X (Print) Linking ISSN: 1868310X NLM ISO Abbreviation: J Community Genet Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: Genetic renaissance: a cross-regional analysis of the approval landscape of authorised gene therapeutics in paediatrics, challenges and future prospects.
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  Data: <searchLink fieldCode="AU" term="%22Ahmad+A%22">Ahmad A</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India.<br /><searchLink fieldCode="AU" term="%22Simran+S%22">Simran S</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India.<br /><searchLink fieldCode="AU" term="%22Kalokhe+VM%22">Kalokhe VM</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India.<br /><searchLink fieldCode="AU" term="%22Musthafa+F%22">Musthafa F</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India.<br /><searchLink fieldCode="AU" term="%22Gangawane+VS%22">Gangawane VS</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India.<br /><searchLink fieldCode="AU" term="%22Choudhary+KK%22">Choudhary KK</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India.<br /><searchLink fieldCode="AU" term="%22Raghuvanshi+RS%22">Raghuvanshi RS</searchLink>; Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India, Directorate General of Health Services, New Delhi, India.<br /><searchLink fieldCode="AU" term="%22Srivastava+S%22">Srivastava S</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India. saurabh@niperhyd.ac.in.; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India. saurabh@niperhyd.ac.in.
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  Data: <searchLink fieldCode="JN" term="%22101551501%22">Journal of community genetics</searchLink> [J Community Genet] 2025 Oct; Vol. 16 (5), pp. 513-528. <i>Date of Electronic Publication: </i>2025 May 21.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer%22">Springer </searchLink><i>Country of Publication: </i>Germany <i>NLM ID: </i>101551501 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Print <i>ISSN: </i>1868-310X (Print) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%221868310X%22">1868310X </searchLink><i>NLM ISO Abbreviation: </i>J Community Genet <i>Subsets: </i>PubMed not MEDLINE
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        Value: 10.1007/s12687-025-00799-y
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        Text: English
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              Text: 2025 Oct
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