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Regulatory affairsRegulatory Round-up - November 2025
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Early dialogue to support development of medicines for childrenEarly dialogue to support development of medicines for childrenFDA issue draft guidance on developing drugs for Duchenne Muscular DystrophyFDA issue draft guidance on developing drugs for Duchenne Muscular DystrophyFDA issues final guidance on early phase clinical trials for gene and cell therapiesFDA issues final guidance on early phase clinical trials for gene and cell therapiesEMA adopts Reflection Paper on Classification of ATMPsEMA adopts Reflection Paper on Classification of ATMPsCell Therapy Catapult and Asymptote Collaborate to Revolutionise Delivery of Cell TherapiesCell Therapy Catapult and Asymptote Collaborate to Revolutionise Delivery of Cell TherapiesTxCell and Trizell amend collaboration agreement to accelerate Ovasave developmentTxCell and Trizell amend collaboration agreement to accelerate Ovasave developmentCell Medica Collaborates with Cell Therapy Catapult to Help Bring Its New Treatment to NHSCell Medica Collaborates with Cell Therapy Catapult to Help Bring Its New Treatment to NHSNewcastle Hosts Major Interactive Science Exhibit Exploring the Wonder of Stem CellsNewcastle Hosts Major Interactive Science Exhibit Exploring the Wonder of Stem CellsComplementary vision and technologies shared in Cell Therapy Catapult visit to the University of LeedsComplementary vision and technologies shared in Cell Therapy Catapult visit to the University of LeedsAthersys and Cell Therapy Catapult announce grant to support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory ConditionAthersys and Cell Therapy Catapult announce grant to support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory ConditionCell Therapy Catapult to create cell therapy manufacturing site in StevenageCell Therapy Catapult to create cell therapy manufacturing site in StevenageCell Therapy Catapult CEO appointed to Board of UK BioIndustry AssociationCell Therapy Catapult CEO appointed to Board of UK BioIndustry Association