Novo Nordisk (NVO) has released an update.
Novo Nordisk, a leader in diabetes care, has received a Complete Response Letter from the FDA regarding their new once-weekly basal insulin icodec, indicating additional requirements related to manufacturing and the type 1 diabetes indication must be met. The company is working with the FDA to address these issues but does not anticipate resolving them within 2024. While facing regulatory hurdles in the US, insulin icodec has already been approved for use in the EU and several other countries for both type 1 and type 2 diabetes.
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