fda sued over tirzepatide FDA's decision creates uncertainty for patients—and leads to a lawsuit Tirzepatide Wins FDA Approval for

The primary endpoint was to demonstrate non-inferiority (with a non-inferiority margin of 0.3%) of tirzepatide 10 mg or 15 mg, or both, compared to glargine in terms of the change in HbA1c from baseline to 52 weeks

Limitations & Unknowns While promising, there remain many uncertainties: Causality not yet proven : Many studies are associative

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