Life-saving treatments for children with orphan illnesses often move slowly, if at all, through the federal approval process.

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 ...

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 ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

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

Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label ...

The FDA declined to endorse leucovorin as a treatment for autism, but approved the drug to treat cerebral folate deficiency, ...

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 ...

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 ...

Add Yahoo as a preferred source to see more of our stories on Google. Leucovorin.Photograph: Hannah Beier/Reuters (Photograph: Hannah Beier/Reuters) This week, the Trump administration announced that ...