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.

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 ...

The FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other medical options. But the process is cumbersome to navigate and strictly ...

A March 9 draft guidance from the FDA proposes an allowance for biosimilar sponsors to use clinical data from outside the U.S. to seek the agency’s approval, which would reduce the requirement of at ...

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 ...

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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

“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 ...