The Latest Breaking News from Food and Drug Administration

The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers

The psychedelics space was shaken up on the news that MindCure Health (OTC:MCURF) was shutting down operations. After a review process, the company’s board decided that MindCure’s business plan required more capital that it could gather under current market conditions, thus shutting down operations was considered the best move to preserve…

The Food and Drug Administration approval calendar was light in February. Nevertheless, the month saw regulatory nods accorded to some breakthrough therapies.

There are three COVID-19 tests distributed in the U.S. to avoid and if you already have any of them, don’t use them, the Food and Drug Administration is warning of the unauthorized tests.

The Food and Drug Administration’s surprise approval of Aduhelm for the treatment of Alzheimer’s disease last year was a mess on practically every level. Three agency advisers resigned, and skeptical doctors such as myself were left to advise patients — all desperate for hope — that, yes, it is a…

Parents hoping to get their young children vaccinated for COVID-19 will have to wait at least another two months. The Food and Drug Administration (FDA) recently postponed a decision on an emergency use authorization of the Pfizer vaccine for kids 6 months to 4 years old. The FDA is waiting…

BioMarin stock tumbled Friday on a Food and Drug Administration setback for its experimental gene therapy in a rare disease.

A video has emerged of a Food and Drug Administration executive suggesting there are plans for annual COVID-19 vaccines to be implemented in the United States.

The Food and Drug Administration outlined new, voluntary guidelines to lower sodium levels in food. But those with high blood pressure or who are at risk for heart disease may want to consider simply saying no to sodium.