An FDA-approved biosimilar is a biological product that is highly similar to and has no clinically meaningful differences in terms of safety or effectiveness from an existing FDA-licensed ...

The Food and Drug Administration launched an “aggressive timeline” on Thursday that charts its internal efforts ... in aiding scientific reviews, FDA Commissioner Martin Makary announced ...

The FDA made the announcement in statement about "an aggressive timeline to scale use of artificial intelligence internally across all FDA centers by June 30, 2025, following the completion of a ...

The FDA said Tuesday that the review -- part of its "Operation Stork Speed" initiative -- will look at whether current nutrient requirements need to be updated, including whether additional ...