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The Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3 in favor of recommending approval for a groundbreaking gene therapy targeting inherited retinal dystrophy, marking a significant milestone in ophthalmology.
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The Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3 in favor of recommending approval for a groundbreaking gene therapy targeting inherited retinal dystrophy, marking a significant milestone in ophthalmology.
New guidance addresses manufacturing, quality controls, and clinical development considerations for cell and gene therapies entering European markets.
British regulatory authority grants breakthrough therapy designation to innovative monoclonal antibody targeting amyloid plaques in Alzheimer's disease.
International Council for Harmonisation publishes comprehensive guidance on statistical methodologies for clinical trials in pharmaceutical development.
Groundbreaking gene editing therapy receives full approval, offering new hope for patients with sickle cell disease and beta-thalassemia.
Comprehensive overview of the updated EU pharmaceutical legislation and its implications for drug development and market authorization processes.
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