Sanofi (SNY) wins FDA label expansion for its MenQuadfi meningococcal vaccine for use in infants as young as six weeks. Read ...

The FDA is delaying implementation of a rule that would require food companies to print nutritional information on the front labels of their products. The proposed rule was developed by President ...

Now, the FDA has an opportunity to show that it’s serious about Americans’ health — by finalizing a rule that would require strong front-of-package nutrition labels across the food supply.

Bristol Myers Squibb BMY announced that it has obtained FDA approval for the label expansion of Opdivo (nivolumab) plus Yervoy (ipilimumab). The regulatory body approved Opdivo plus Yervoy as a ...

On Feb. 28, 2025, FDA informed testosterone product sponsors of new changes to labeling, after the agency reviewed findings from a clinical trial and results from required postmarket ambulatory blood ...

Feb 28 (Reuters) - The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on results from clinical and post-market studies testing the ...

Feb. 25, 2025 – The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to start and keep up with ...

Having a tough time reading those food labels? And what constitutes healthy, and can you believe what manufacturers say on a package? The U.S. Food and Drug Administration is trying to help.

In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med Izervay has nabbed a much-needed label update from the FDA. The agency ...

So, what do terms like “FDA-approved,” “FDA-cleared,” and “FDA-regulated” mean—and why do these labels matter? Understanding the differences will help you cut through the buzzwords ...

(Scott Olson/Getty Images) In the final days of the Biden administration, the Food and Drug Administration proposed a front-of-package food label that is eye-catching and informative and would ...

The US Food and Drug Administration (FDA) is urging manufacturers to revise labeling of transmucosal buprenorphine products to ease access to higher doses needed due to the rise of high-potency ...