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

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

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

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

Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® ...

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 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 ...