Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 importation program (SIP), which allows…

The U.S. Food and Drug Administration today approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma…

The U.S. Food and Drug Administration today issued a Request for Information (RFI) seeking public comment on potential new standards for in-home opioid disposal products….

The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded…

The U.S. Food and Drug Administration today issued an approval for the lung cancer drug Hernexeos (zongertinib) as a part of the new Commissioner's National…

The U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and…

The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed…

The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to…

The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food. The review will consider…

Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply from the use of artificial petroleum-based…