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

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

Explore cutting-edge methods for detecting alcohol biomarkers and drugs of abuse using alternative sample matrices.

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

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

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

Vanda Pharma announces Bysanti NDA with US filing; US FDA decision expected in early 2026: Washington Tuesday, May 6, 2025, 18:00 Hrs [IST] Vanda Pharmaceuticals Inc. (Vanda) anno ...

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

Investing.com -- Novo Nordisk (NYSE: NVO) shares climbed 5.4% Friday after the U.S. Food and Drug Administration accepted 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 ...

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 ...