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

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

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

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

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

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

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.

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

Few areas of healthcare are as sensitive as cancer treatment. Each year, around 44,000 cancer tumours are diagnosed here.

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 ...