Novo (NVO) Gets CRL From FDA for Weekly Basal Insulin Icodec
NVONovo Nordisk(NVO) ZACKS·2024-07-12 00:31

Novo Nordisk (NVO) announced that it has received a complete response letter from the FDA for its biologics license application (“BLA”) for once-weekly basal insulin icodec.The BLA seeks approval for once-weekly basal insulin icodec for the treatment of diabetes mellitus. The application was submitted in April 2023.The FDA requested information related to the manufacturing process and the type 1 diabetes indication before it can complete the review of the application.Novo is evaluating the content of the CR ...