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

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

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

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 ...

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

A new drug application seeking the approval of ziftomenib was submitted to the FDA on April 8, 2025. This indication is for ...

A decision is expected in the fourth quarter of 2025.