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BPC-157 Is Classified as an Unapproved New Drug According to the FDAs definition, any substance that claims to treat, diagnose, cure, or prevent disease is considered a drug. If it hasnt gone through the FDAs rigorous review and approval process, its classified as unapproved and illegal to market or distribute for human consumption

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Last month (May 2025), Novo announced that the US Food and Drug Administration (FDA) accepted its new drug application (NDA) submission for an investigational once-daily oral formulation of Wegovy (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease

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