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

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 ...

(CNN) — A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children. In ...

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

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

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 ...

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