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.

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

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.

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 comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee (ODAC) voted that the drug does not have a favorable benefit-risk profile in combination with either of two different regimens for patients with relapsed and refractory multiple myeloma.

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

Altogether, FDA-regulated products make up about 20 percent of consumer purchases in the United States. The agency typically makes decisions on about fifty new drug and biological products every year.

The United States Food and Drug Administration (FDA) announced on May 22 that certain frozen, raw and half-shell oysters from South Korea could be infected with norovirus.. According to a news ...