The FDA cleared Novo Nordisk’s once-weekly basal insulin Awiqli (insulin icodec) injection 700 units/mL for type 2 diabetes, giving the U.S. market its first approval for a once-weekly long-acting insulin in this indication. The approval positions the product as a longer-acting alternative to daily basal insulin regimens. The clearance followed a regulatory process that had been in motion since 2023 across multiple territories. Novo Nordisk secured the U.S. approval after similar success abroad, according to the report. For biotech and pharma competitors, the decision increases pressure in diabetes product differentiation around adherence, pharmacokinetics, and real-world persistence. It also reshapes the competitive set for next-generation basal insulins entering late-stage review.