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Intercepts NDA application was based on an interim analysis from their 18-month Phase 3 REGENERATE (ClinicalTrials.gov NCT02548351) clinical trial of Obeticholic acid with nearly 2500 NASH patients with fibrosis enrolled (Figure 1)

In our latest ClinPharm Pulse deep dive, I break down the 4 pillars of the new guidance: Context of Use (COU): Defining your regulatory goal

For lasting weight loss, its best to follow a longer-term plan under medical supervision to gradually adjust dosage and maintain results

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Los medicamentos antidiabticos orales tambin se administran una o varias veces al da

Otherwise, it works in the same exact mechanism as the injectable GLP1 agonists