A Phase I/II trial is set to assess the therapy’s potential efficacy and safety, as well as determine an appropriate dose.

Cytokinetics' PDUFA date for aficamten was extended to December 26th of 2025, due to the FDA's need to review a submitted ...

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

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 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.

Quantum Biopharma plans to file an application by year's end seeking FDA clearance for a Phase 2 clinical trial testing Lucid ...

There could be an upside to incorporating AI for the FDA. Using AI to assist in final drug reviews would "represent a chance ...

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 ...