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Tag: basal insulin


FDA, Regulations

FDA rejects Novo Nordisk’s weekly basal insulin

July 11, 2024

Via: Pharmaphorum

The FDA sent the Danish drugmaker a complete response letter (CRL) declining to approve the drug, insulin icodec, saying that it needs more information on its manufacturing process, as well as more data on how well it performs in people with […]


Clinical Trials, Research and Development

Novo Nordisk achieve headline results with icodec insulin

October 4, 2022

Via: Pharmaphorum

Compared to once-daily basal insulin (insulin degludec or insulin glargine U100/U300) analogues, the 52-week ONWARDS 5 trial – an open-label efficacy and safety treat-to-target study of 1,085 insulin-naïve people with type 2 diabetes in a clinical practice setting – achieved […]