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 ...

Verastem will launch a U.S. phase 1/2a trial of oral KRAS G12D inhibitor VS-7375 after FDA IND clearance, with data to be ...

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® ...

has officially approved the New Drug Application (NDA) for VELSIPITY ® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). VELSIPITY ® is ...

Verastem Oncology said Wednesday that the Food and Drug Administration cleared the company's investigational new drug application for its potential treatment of certain cancers.

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 ...