A PDUFA date (Prescription Drug User Fee Act date) is the FDA's target deadline to complete their review and issue a decision on a New Drug Application
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The short answer is yes, but getting this wrong is expensive
Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: a phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes