The FDA's groundbreaking decision to waive clinical efficacy studies for a monoclonal antibody biosimilar revolutionizes drug approval, reducing costs and enhancing patient access.

By harmonizing their patient engagement frameworks, the FDA and CMS can transform parallel efforts into a unified pathway ...

Drugmaker Eli Lilly said on Tuesday it is launching an artificial intelligence and machine learning platform that provides ...

The US Food and Drug Administration approved updated Covid-19 vaccines but for a more limited group: adults age 65 and older ...

To increase transparency, the agency is publishing data from the FDA Adverse Event Reporting System daily rather than quarterly.

Under the Trump administration, the Food and Drug Administration is eagerly embracing artificial intelligence tools that staff members are reportedly calling rushed, buggy, overhyped, and inaccurate.

To hear health officials in the Trump administration talk, artificial intelligence has arrived in Washington to fast-track new life-saving drugs to market, streamline work at the vast, ...

The approval presents barriers to access for millions who will have to prove their risk — and millions more who may want to ...