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

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

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

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

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

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

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

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

For five years, the clinical-stage pharmaceutical company has developed Enbumyst, a nasal spray intended to remove excess ...

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 ...