The FDA enlisted British drugmaker GSK to help it fast-track approval of leucovorin to treat an autism-related disorder.

The agency expanded use of an old drug as a treatment for some people with autism. The endorsement sent some customers ...

The U.S. Food and Drug Administration said on Friday that it has launched a new pilot program to speed up the review process ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

Artificial intelligence is poised to dramatically reshape the process of developing and approving new medicines, according to ...

The company stated that data from a planned pivotal study will be pooled with data from the ongoing Phase I/II studies of ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...