The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

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

FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

The Food and Drug Administration is reconsidering its decision not to approve a drug that an Omaha mom says is saving her son ...

The FDA has approved a twice-yearly injection for HIV prevention following a groundbreaking clinical trial. Years before the ...

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Embrelis marks a pivotal moment ...

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

The U.S. Food and Drug Administration has appointed George Francis Tidmarsh, M.D., Ph.D., as director of the Center for Drug Evaluation and Research (CDER).