The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

The FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...

The FDA proposed new guidelines for approving experimental therapies for rare diseases without large group studies.

“Designing treatments unique to individual patients has always been the promised goal of personalized medicine. After 25 years the FDA has, for the first time, outlined a framework to facilitate these ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

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 ...

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.

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 ...

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 ...