The FDA often issues warning letters after initially flagging its concerns to a company and determining the company’s ...

Three months later, one of those arrows has missed its target as the FDA has sent Regeneron a complete response letter (CRL), rejecting ... two quarters of 2024, for example, sales of Eylea ...

A seafood company failed to follow federal safety rules to prevent potential botulism contamination. A business was hawking dietary supplements with the misleading claim that they’d cure, treat ...

The FDA has not published more than a dozen letters that flagged hazards at food companies, including potential contamination, two sources said. NBC Universal, Inc. A seafood company failed to ...