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

The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug ...

The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.

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

In a precedential decision issued May 6, 2025, the Federal Circuit reversed in part and vacated in part a Delaware district ...

The investigational transdermal delivery system, known as Xulane Lo, is designed to deliver 150mcg of norelgestromin and 17.5mcg of ethinyl estradiol per day.

Viatris shares favorable Phase 3 data for contraceptive patch and pain drug, affirms 2025 sales, and raises adjusted EPS ...

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

The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...