GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the proposed dosing regimen.

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 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 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.

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

Philadelphia man sentenced to 15 years for leading a drug operation, involving heroin, cocaine, and fentanyl distribution.

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.

In Rehab, journalist Shoshana Walter investigates the systemic pitfalls of drug treatment programs, which prevent people’s recovery from addiction.

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed foods are often targeted toward children and said the agency has focused on fighting childhood obesity and diabetes.

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