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.

Vesicor Therapeutics, a San Gabriel-based biotech firm developing p53-based cancer treatments, is set to go public through a ...

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

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

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

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

Eraglusib with gemcitabine and nab-paclitaxel achieved statistical significance in the first-line treatment of metastatic ...

Viatris shares favorable Phase 3 data for contraceptive patch and pain drug, affirms 2025 sales, and raises adjusted EPS ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

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 ...