The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

People with an allergy or severe sensitivity to peanuts "may risk serious or life-threatening allergic reactions by consuming ...

The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...

The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and ...

The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II ...

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time ...