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

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.

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...

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

For decades, government intervention into the health care sector has increased at the expense of individual freedom. This disturbing trend is especially prevalent when it comes to the antiquated drug ...

The Food and Drug Administration (FDA) on Tuesday granted expanded approval to Wellcovorin for the ultra-rare disease cerebral folate deficiency (CFD) in both children and adults, the same ...

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 ...

The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay Prasad will help clear the path.