The FDA expanded the indication for finerenone (Kerendia) in heart failure (HF), drug manufacturer Bayer announced.

Needle mushrooms and other mushroom products are impacted by two separate recall notices from the Food and Drug ...

(Reuters) -British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to ...

Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic ...

The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering evergreen, for use in a variety of drinks and candies.

A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...

The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...

While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

FDA is urging manufacturers of infant formula, baby food and children’s nutrition products to sharpen their recall ...

In his first 100 days as commissioner of the Food and Drug Administration, Marty Makary has made a handful of splashy ...

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...