The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies regarding the abortion pill mifepristone.

Last week, the FDA had issued a warning about a “Dubai chocolate” spread available in US markets after it tested positive for ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...