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

In the first quarter, BioCryst swung to a profit of $32,000, or less than a penny a share from a loss of $35.4 million, or 17 cents a share, a year earlier. Revenue surged 57% to $145.5 million, ...

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 ...

The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML. A New Drug Application (NDA) has been submitted to the Food and Drug Administration ...

Perspective from Michael DeCourcey, MD Tenpoint Therapeutics submitted a new drug application to the FDA for Brimochol PF, an eye drop for presbyopia treatment, according to a press release.

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 ...