The panelists said that vaginal creams and other localized therapies for menopause are safe and vastly underused by women who could benefit.

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

An agency-sponsored forum included critics of psychiatry who believe the drugs can harm a developing fetus. Other experts ...

Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...

Doctors on Monday urged the U.S. Food and Drug Administration to issue warnings to pregnant women against the use of certain ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

The Food and Drug Administration is shifting its annual COVID-19 vaccine approval policies to focus on Americans older than age 65 and other "high-risk" individuals, while increasing the standard ...

The FDA subsequently issued is Class I risk classification on July 3. Vita Warehouse Corp. issued a voluntary recall for more than 40,000 bottles of Vitamin B12 supplements on June 12 because of ...

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with ...

The FDA announced Tuesday that, going forward, COVID-19 vaccines would be approved only for people over age 65 or those at risk for severe infection.. The move will streamline the approach to ...

The FDA will prioritize approval of COVID-19 vaccines which can be proven to generate antibody titers in people over age 65 or people who are 6 months or older and at high risk for severe disease ...

In a major policy change, the Food and Drug Administration has announced a plan to limit access to future COVID-19 shots only to people over 65 years old or those with an underlying health condition.