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 ...

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® ...

A research team from the University of Oklahoma has pioneered a method that could accelerate drug discovery and reduce ...

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 ...

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

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

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

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 ...