The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.

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

The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.

The matter was discussed during the 92nd DTAB meeting held on April 24, 2025. The Board was apprised with respect to ...

accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® (semaglutide) for chronic weight management in adults living with obesity ...

People taking lorundrostat experienced twice the decline in their systolic blood pressure than people taking a placebo, ...

Shares of biopharmaceutical company Cytokinetics were trading in the red in the after-hours market following news the Food and Drug Administration extended the prescription drug user fee act action ...

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

Novo Nordisk NOVO.B-3.93%decrease; red down 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 ...