Many also don't think testosterone should be considered a schedule III substance ...

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 ...

ACC makes its case for front-of-package nutrition labeling ...

On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) nutrition labeling (“proposed rule”). 1 If finalized, the ...

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

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.

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 ...

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 ...

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