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 ...

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

The FDA has approved a new higher-dose version of Wegovy, a weight-loss drug, enhancing treatment options for obesity with improved efficacy and availability.

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

FDA worked with GSK to update Wellcovorin labelling for safe, effective use in adult and paediatric CFD-FOLR1 patients.

In taking the unusual step of approving an old generic drug as a treatment for autism, the Food and Drug Administration stunned some experts by departing sharply from the agency’s typical standard for ...

The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and political priority setting.