FDA Commissioner Dr. Marty Makary announces the acceptance of broader real-world data in medical applications, ending previous requirements that limited submissions.

The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines.

Supplements aren’t reviewed for safety and effectiveness, but disclaimers about health benefits are required on products.

The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's Enhertu in combination with Roche's drug, Perjeta, for the first-line treatment of patients with a type of breast cancer,

The U.S. Food and Drug Administration is considering adding the strongest safety warning available to COVID-19 vaccines, alarming many experts.

U.S. health officials have expanded approval of a drug that boosts libido in women who report stress due to a low sex drive.

The U.S. Food and Drug Administration has approved a new indication for Breyanzi (lisocabtagene maraleucel) for treating adults with marginal zone lymphoma (MZL) who have failed treatment or relapsed after two or more prior lines of therapy.

Pro-life groups are holding the U.S. Food and Drug Administration and its commissioner Marty Makary accountable for leaving its promise to review the “dangerous” abortion drug mifepristone continually unfulfilled, with one organization calling for the commissioner to be fired due to his having “slow-walked” the review.