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

The FDA accepted Novo Nordisk's NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the ...

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

Mumbai: Global pharma major Lupin Limited has announced that the company has launched Eslicarbazepine Acetate Tablets, 200 mg ...

The product, available in 200 mg, 400 mg, 600 mg, and 800 mg strengths, is the generic equivalent of Sumitomo Pharma ...

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

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 ...

The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.

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

Novo Nordisk NOVO.B-3.93%decrease; red down 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 ...