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 ...

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

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

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 ...

Please provide your email address to receive an email when new articles are posted on . The pathway aims to streamline approval for individualized treatments for rare and ultra-rare diseases. An ...

“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 ...

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 ...

March 5 (Reuters) - The U.S. Food and Drug Administration on Thursday approved Johnson & Johnson's treatment for a type of ...