Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

Bristol Myers Squibb BMY announced that it has obtained FDA approval for the label expansion of Opdivo (nivolumab) plus Yervoy (ipilimumab). The regulatory body approved Opdivo plus Yervoy as a ...

Exelixis, Inc. EXEL announced that the FDA has approved the label expansion of its lead drug Cabometyx (cabozantinib). The regulatory body approved Cabometyx for the treatment of adult and ...

Eli Lilly and Co., the maker of Zepbound and Mounjaro, announced a successful Phase 3 trial for a once-daily GLP-1 pill for ...

The FDA has updated the definition of "healthy" on food labels to better reflect current nutritional science. Foods must now meet criteria for beneficial nutrients and limits on added sugars, ...

Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is, I believe, a ...