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The FDA's guidance addresses whether such combinations may be considered essentially a copy of an FDA-approved product, depending on route of administration and strength, and notes that individual clinical justification should be documented

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Conclusions GLP-1 agonists reduce fetal survival, weight, growth and skeletal ossification and can induce major congenital anomalies

Novo Nordisks drug Wegovy drove billions of dollars in revenue for the drug-maker, but lawmakers have criticized the wide gap between U.S