FDA

The FDA approved the use of Leqembi in January for patients with mild or early cases of dementia tied to Alzheimer’s. A year’s treatment runs about $26,500, and there are few options outside of self-pay.

A new human foods program will be led by a deputy commissioner with authority over policy, strategy and regulatory activities for the part of the agency that oversees 80% of the foods Americans eat.

Long criticized as discriminatory, the policy has prevented many men who have sex with men from donating blood. The FDA is expected to reveal its new approach on Friday.

A single booster seems to prevent death and hospitalization in most people, but protection from the current vaccines wanes within months. FDA experts say they need to know more from the CDC to decide the best long-term strategy.

Advisers to the U.S. Food and Drug Administration today endorsed a proposal to make big changes in the nation's approach to vaccinating people against COVID-19.

Frank Yiannas, the deputy commissioner for food policy and response since 2018, told FDA Commissioner Dr. Robert Califf in an email that he would leave Feb. 24.

Toxic metal can be harmful to developing brains. New lead targets are part of a broad FDA initiative to reduce children's exposure to the lowest levels possible.

The new approach would simplify vaccination guidance so that, every fall, people would get a new shot, updated to try to match whatever variant is dominant.

In the wake of an FDA decision that allows pharmacies to stock the medication, the Florida agency warned providers that “criminal penalties” could result over violations.

In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.