The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...

(AI). AI technologies such as machine learning, computer vision, natural language processing and reinforcement learning ...

Shares of Sana Biotechnology Inc. (NASDAQ: SANA) were trading at $4.97, up $3.32, or 201%, on first results from an investigator-sponsored, first-in-human study transplanting UP-421, an allogeneic ...

The US FDA has introduced voluntary guidelines on the level of lead content in processed baby foods sold in the country.

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...

Critics, however, say the move is too little, too late. Other FDA and pharma news is on AI-enabled medical devices, smaller PBMs, and more.

The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...

The FDA has responded to the increasing use of artificial intelligence (AI) in the discovery and development of drugs and ...

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial ...

The FDA will decide later this month whether to approve a novel drug for acute pain that could offer a nonaddictive ...