Failed!
That was the overall message from the FDA in a complete response letter to the Danish pharma giant Novo Nordisk. The letter comes in response to Novo’s application for approval of the company’s new long-acting insulin Tresiba and the combination drug Ryzodeg for the US market. The letter informs that Novo Nordisk can only gain approval by carrying out additional clinical testing of the drugs to establish cardiovascular safety.
Allerede abonnent? Log ind.
Læs hele artiklen
Få adgang i 14 dage for 0 kr.
Det kræver intet kreditkort, og du vil ikke overgå til et betalt abonnement efterfølgende.
- Adgang til alle låste artikler
- Modtag vores daglige nyhedsbreve
- Fuld adgang til vores app