The FDA approved Novo Nordisk’s Awiqli (insulin icodec) injection 700 units/mL, making it the first and only once-weekly, long-acting basal insulin in the US. The approval gives Type 2 diabetes patients a longer-interval alternative to daily basal regimens. Novo’s path to the US finish line was shaped by regulatory review that began in 2023 and succeeded in other territories, setting up a US-specific milestone for the company’s basal insulin franchise. The label approval reinforces the commercial push for simpler dosing schedules in diabetes management. Clinicians and payers will now assess how once-weekly basal insulin fits into treatment algorithms relative to existing daily basal insulins and GLP-1–based combinations.