May has just begun, and it's time to turn our attention to the FDA decisions on deck for the coming weeks.So far this year, the U.S. regulatory agency has approved only ...

The FDA’s decision to ban dyes and other synthetic substances often rests on the Delaney clause, a 49‑word law from 1958 that ...

Prior to starting the trial, the participants also had moderate to high levels of scar tissue in the liver, known as stage 2 ...

Retail investor interest in Q32 Bio Inc picked up on Wednesday after the clinical-stage biotech said the U.S. Food and Drug ...

The Food and Drug Administration is attempting to phase out petroleum-based synthetic blue, red, yellow, green dyes in favor ...

The FDA and USDA have launched a joint investigation into a new outbreak of Listeria monocytogenes infections. The source of ...

"This is the best thing that's happened to me," a Nebraskan with Alzheimer's Disease said, "to be able to deal with it ...

The FDA announced a recall on 63,000 pounds of Grain Millers' oats, which may have been contaminated with plastic.

The US Food and Drug Administration will require all new vaccines go through placebo-controlled studies before they are ...

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

People who have a sensitivity or allergy to milk may be at risk of an adverse reaction if they consume this product.

The potential change outlined in a statement would require all new vaccines to undergo “placebo” testing, sparking concerns ...