Vinay Prasad, director of the Center for Biologics Evaluation and Research, will leave the FDA at the end of April, an agency spokesperson confirmed on Friday. It is his second departure from the position: He briefly left the post in July following backlash over his regulatory decisions, and returned only two weeks later in August.

Exposure to this product could cause miscarriages and stillbirths as well as serious infections.

Commissioner Marty Makary on Friday announced that the agency’s top regulator Vinay Prasad will depart next month. “A year ago, Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement,

Physicians remain wary of the wellness trend

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent decision on an experimental medicine,

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

By Michael Erman and Puyaan Singh March 5 (Reuters) - A senior FDA official called UniQure's experimental treatment for Huntington's disease a "failed product" in a conference call with media on Thursday,

Katie Jackson desperately wants a new treatment for Huntington’s disease. Her husband died from the devastating brain disorder. And because the disease runs in families, her three children have a 50% chance of inheriting the condition.