Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

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.

Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat ...

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

The investigational transdermal delivery system, known as Xulane Lo, is designed to deliver 150mcg of norelgestromin and 17.5mcg of ethinyl estradiol per day.

The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug ...

Novo Nordisk NOVO.B3.59%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 ...

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 ...