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Regulatory agencies such as the FDA and EMA classify live modified microorganisms as higher-risk biological products, necessitating extensive preclinical safety evaluation, including assessment of genetic stability, exclusion of horizontal gene transfer, immunogenicity testing, and environmental biosafety analyses (Rouanet et al., 2020

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A Novo Nordisk, farmacutica responsvel pelo medicamento, anuncia que ele estar disponvel a partir de agosto de 2024