The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milsaperidone (Bysanti™) for the treatment of acute ...

A new drug application seeking the approval of ziftomenib was submitted to the FDA on April 8, 2025. This indication is for ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much ...

Verastem will launch a U.S. phase 1/2a trial of oral KRAS G12D inhibitor VS-7375 after FDA IND clearance, with data to be ...

has officially approved the New Drug Application (NDA) for VELSIPITY ® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). VELSIPITY ® is ...

Shares of biopharmaceutical company Cytokinetics were trading in the red in the after-hours market following news the Food and Drug Administration extended the prescription drug user fee act action ...

Investing.com -- Novo Nordisk (NYSE: NVO) shares climbed 5.4% Friday after the U.S. Food and Drug Administration accepted the ...

Novo Nordisk NOVO.B2.62%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...