
FDA Advisory Committee Recommends Approval for Novel Gene Therapy
The Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3 in favor of recommending approval for a groundbreak...
Read MoreComprehensive overview of UK regulatory requirements and opportunities following Brexit.
The MHRA will host a comprehensive webinar on September 5, 2025, addressing the evolving regulatory landscape in the UK following Brexit and the opportunities for pharmaceutical innovation.
The session will cover key aspects of the UK's independent regulatory framework:
Advance Regulatory Consulting has successfully supported over 200+ pharmaceutical and biotech companies in navigating complex regulatory pathways. Our team of former health authority experts provides strategic guidance from early development through market authorization and beyond.
Partner with regulatory experts who deliver resultsThe webinar will highlight the UK's commitment to regulatory innovation:
Navigate the post-Brexit UK regulatory landscape with our comprehensive market access and regulatory strategy services.
Learn MoreOur UK Regulatory Team consists of experienced regulatory professionals with deep expertise in pharmaceutical development and regulatory strategy.
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The Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3 in favor of recommending approval for a groundbreak...
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New guidance addresses manufacturing, quality controls, and clinical development considerations for cell and gene therap...
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British regulatory authority grants breakthrough therapy designation to innovative monoclonal antibody targeting amyloid...
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