The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet on May 24 to review Novo Nordisk A/S’s (NYSE:NVO) application seeking approval for a once-weekly insulin icodec. In December 2023, the FDA said that data submitted by Novo Nordisk during the regulatory review is considered to constitute a major amendment to the Biologics License Application (BLA) for insulin icodec.  Therefore, the regulatory review is extended by three months to provide time for a full submission review. Novo Nordisk expects the review to be completed during the third quarter of 2024. In an FDA briefing document, agency staff said the data ...