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.

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

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 ...

U.S. inspectors have uncovered new and dangerous breakdowns in drugmaking at an Indian factory owned by Sun Pharma that produces generic medications for American consumers.