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FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes
Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: results of the LEADER and SUSTAIN 6 trials
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