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

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 ...

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

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

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

A new pill, tavapadon, has shown potential in easing Parkinson’s symptoms while limiting side effects. In patients taking at ...

FDA seeking 'aggressive' adoption of AI . The FDA announced an "aggressive timeline" to deploy artificial intelligence ...

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

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

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