The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...

Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing ...

“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development — ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

The new CNPV program will allow drug developers to participate in a novel FDA priority program that significantly shortens the review time for a final drug application from approximately 10-12 ...