Members of an FDA expert panel urged the agency to expand labeling for testosterone replacement therapy and remove its ...

The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the ...

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...

The FDA's proposed rule would require food manufacturers to put "Nutrition Info" boxes on the front of their packages stating ...

FDA rolls out agentic AI tools to assist staff with inspections, reviews, and compliance, enhancing workflow efficiency and oversight.

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda Pharmaceuticals is pursuing a new route to establish the drug in the space. Hetlioz was ...

FDA’s proposal to mandate front-of-pack nutrition labeling that quantifies and qualifies the percent daily value of saturated fat, sodium and added sugar to help consumers more easily make informed ...

The FDA is requiring manufacturers of opioid pain medications to update safety labels to better emphasize risks linked to their long-term use, the agency announced in a new Drug Safety Communication.

Many of us assume that the US Food and Drug Administration approves all of our personal care products, vetting every serum, supplement, and LED mask. After all, on average, people slather on six to 12 ...

Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to ...

The FDA approved the combination of durvalumab (Imfinzi) plus FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and ...