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

Novo Nordisk said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on ...

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 ...

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 ...

Everest Medicines (HKEX 1952.HK, 'Everest', or the 'Company'), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative ...

Ziftomenib’s FDA application for relapsed/refractory NPM1-mutant acute myeloid leukemia is supported by data from the KOMET-001 trial. A new drug application (NDA) seeking the approval of ziftomenib ...

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.

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 ...