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FDA nonclinical toxicology review (2023-2024) flagged DNA damage in pituitary cells and injection-site necrosis in animal studies, plus immunogenicity and impurity risks from compounded material, alongside GH/IGF-1-axis effects such as fluid retention, joint discomfort, flushing, and headache reported by users

The duration of each IV treatment can vary depending on the specific treatment plan and type

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The plaintiffs contended that localized access challenges, compounded demand, and affordability issues for patients were not sufficiently considered in the FDAs assessment

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