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 ...

Johnson & Johnson (J&J) has reported more data supporting the efficacy of its intravesical drug release system TAR-200 in ...

action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified ...

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 ...

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 ...

Novo Nordisk said the Food and Drug Administration has accepted its submission of a new drug application for a Wegovy pill to treat obesity. The Bagsvaerd, Denmark, company said Friday that if the ...

Novo Nordisk said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on ...