The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.

The U.S. Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods this ...

SGT-212 is the company's novel, AAV-based FA gene therapy candidate designed to deliver full-length frataxin via systemic intravenous (IV) infusion as well as direct intradentate nuclei (IDN) infusion ...

The food was packaged in clear plastic and sold primarily in retail stores in Virginia, Maryland, Pennsylvania, Connecticut, Massachusetts, and New York.

Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

Congress recently extended Medicare telehealth flexibilities that waive a requirement for an in-person visit before a patient ...

When it comes to weight loss drugs, Ozempic has become a phenomenon. With nearly $14 billion in sales in 2023, it shows no ...

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...

An expert warned that Biden's FDA is advancing a ban on most current cigarettes in a "gift" to drug cartels and other ...

By Sneha S K and Sriparna Roy (Reuters) - The U.S. Food and Drug Administration said on Friday that it has approved an ...

The FDA is alerting healthcare providers about a potential high-risk issue with certain Baxter Healthcare Solution Sets with Duo-Vent Spikes. Baxter has issued a recall for several lots of these ...