On January 20, 2026, the Food and Drug Administration's (FDA) new traceability rules — dubbed the Food Traceability Final ...

The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

After years of pressure, the FDA said it is strengthening its review of many chemical additives used to enhance color, ...

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. In a new ...

Hundreds of foods are recalled by the FDA every year. Food recalls could fall into different categories, depending on how ...

The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign ...

The FDA claimed these clinics were plying patients with an illegal drug derived from their stem cells. A federal court agrees ...

Clinical laboratory lobbying groups are suing the FDA over its plans to more strictly regulate lab-developed tests. For now, ...

The panel agreed with the FDA that the treatment in which a patient's tissue is processed doesn't fall under the same ...

At your next routine mammogram, your report will include results on a new risk factor for breast cancer: dense breast tissue.

The U.S. FDA’s approval of yet another indication for Dupixent (dupilumab), partnered between Regeneron Pharmaceuticals Inc. and Sanofi SA, could mean another $6.4 billion-plus in sales by the end of ...

For years, kratom has been clouded by controversy, largely fueled by media portrayals that paint a negative picture of this ...