FDA Commissioner Martin Makary discusses vaccine policy, COVID-era decisions and the erosion of trust in government health guidance.

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 much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by postmenopausal women up to 65 years old. The announcement Monday from the Food and Drug Administration broadens the drug's use to older women who have gone through menopause.

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

The FDA has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants.

The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say may cause unfounded concerns over safety

French drugmaker Sanofi on Monday flagged another delay to a U.S. regulatory decision for its experimental multiple sclerosis drug and reported disappointing results from a late-stage study, sending shares of the company down 2%.

US health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by women older than 65. The announcement Monday from the Food and Drug Administration broadens the drug’s use to older women who have gone through menopause.

Forbes contributors publish independent expert analyses and insights. Dr. Lance B. Eliot is a world-renowned AI scientist and consultant. In today’s column, I examine the recently published FDA life-cycle scenario underlying AI-enabled mental health devices.