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

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

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

For five years, the clinical-stage pharmaceutical company has developed Enbumyst, a nasal spray intended to remove excess ...

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® ...

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

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 ...