In 2019, the FDA issued a complete response letter regarding Vanda’s application to expand Hetlioz's label to include people experiencing sleep issues from jet lag. Following an unsuccessful ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. A disease detection chatbot ...

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 ...

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.

So, what do terms like “FDA-approved,” “FDA-cleared,” and “FDA-regulated” mean—and why do these labels matter ... reserved for Class III medical devices and prescription drugs.

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 ...

The Food and Drug Administration on Tuesday unveiled a proposal, long in the works, for a mandatory food labeling system that it says is intended to combat chronic diseases, including heart ...

The Food and Drug Administration has proposed its long-awaited front-of-pack labeling rule, featuring a black-and-white nutrition box that lists information on saturated fat, sodium and added sugars.

Nutrition labels on your favorite grocery items may soon sport a new look. The Food and Drug Administration announced a new proposal Tuesday that would require food and drink manufacturers to ...

Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking label expansion of Lumryz. The drug is now approved in the United States ...

Wearable AF monitoring devices are extensively used in routine practice worldwide. The FDA has agreed on the use of AF monitoring devices in clinical trials for budiodarone approval. The FDA has ...

Oct. 16, 2024 — Before the FDA allows prescription medicines on the market, drugmakers must prove they’re safe and effective. What’s less widely known is that most medical devices ...