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

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

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

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

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 ...

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

The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.