Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the fight between Novo Nordisk and Hims & Hers over ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications. By the end of the ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

A Las Vegas-based biotech CEO has a vision of Nevada as a hub for medical innovation, and he is hoping voters will help him ...

Drug makers now need government approval for any quality changes to medicines. This applies to alterations affecting a drug's ...