No-go for Novo

FDA's dogged effort to uncover any potential cardiovascular risk associated with Novo Nordisk A/S's insulin degludec products effectively raised the bar for approval twice, leaving the company and patients facing a prolonged delay in the U.S.

FDA first waved off a CV risk analysis of Tresiba insulin degludec and Ryzodeg insulin degludec/insulin aspart that had been agreed with the company...