Setback for diabetes innovation: FDA puts brakes on Novo Nordisk’s once-weekly insulin icodec
Novo Nordisk announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application for its once-weekly basal insulin icodec, intended for the treatment of diabetes mellitus. This response highlights challenges related to the manufacturing process and concerns specific to the type 1 diabetes indication, delaying […]