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 ...

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

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.

Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...

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, ...

DAP Health has received the new twice-yearly injection for HIV prevention. Here's what you need to know if you're interested ...

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).

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...