The crackdown comes as the FDA has scaled back enforcement in recent decades. The agency once sent more than 100 warning ...

Ocaliva, approved for primary biliary cholangitis, faced FDA warnings and restrictions after postmarket data showed higher ...

Gina Marie Bakery announced a voluntary recall of various cookie products on September 10 over possible undeclared allergens.

The FDA has issued a public health alert for Jiva Organics ground cinnamon due to elevated lead levels, advising consumers to ...

President Donald J. Trump signed a new memorandum that aims to crack down on “misleading” direct-to-consumer pharmaceutical ...

FDA intensifies efforts against misleading drug advertisements, aiming for transparency and accountability in pharmaceutical marketing practices.

Shang Hao Jia Inc. issued a voluntary recall for select lots of three varieties of soda biscuits following a labeling error.

The agency is proposing a requirement that companies submit data when self-affirming an additive is safe for consumption.

The FDA said in letters to five sunscreen makers that they are not authorized to market sunscreen sold in mousse or whipped form.

The company, which inked a deal back in 2008 to supply Pfizer with APIs, was given 15 days from the date the warning was issued to respond or risk having its Jigani plant placed on the FDA's import ...

Shrimp from Indonesia contaminated with man-made Cesium-137 found at US ports, FDA warns consumers not to eat Great Value ...

The vaccine advisory committee is scheduled to meet next week to review and make recommendations for this fall’s updated ...