The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even after banning the factory from the U.S. market because of quality problems.

A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the second-highest risk warning given by the FDA.

The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The Hill.

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL patients who are not eligible for autologous stem cell transplant, Roche and its subsidiary Genentech said Friday.

Drug seizures in the United States are on the rise, with Customs and Border Protection reporting that it has seized more than 60,000 pounds of drugs in June alone.

The U.S. government is nixing a whole slew of "obsolete" U.S. food standards that Trump administration officials say also include "unnecessary" ones.

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S. that will no longer be administered under an emergency use authorization.

The team spent 14 months investigating and found that the FDA had allowed more than 150 potentially unsafe drugs in the U.S.