rejected

JHVEPhoto/iStock Editorial via Getty Images Novo Nordisk (NVO) announced Thursday that the U.S. Food and Drug Administration (FDA) declined to approve its once-weekly insulin product, insulin icodec, targeted at patients with diabetes mellitus (DM). Issuing a complete response letter, the regulator has requested information related to its manufacturing process andContinue Reading

JHVEPhoto The U.S. Food and Drug Administration (FDA) has declined to approve an antibody-drug conjugate known as HER3-DXd developed by Merck (NYSE:MRK) and Daiichi Sankyo (OTCPK:DSKYF) as a late-line option for a certain type of lung cancer. The companies announced Thursday night that the agency issued a so-called complete responseContinue Reading