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 ...

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

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

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

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).

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 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 ...

DSHEA struck a balance between providing easy, affordable access to dietary supplements and maintaining safety and efficacy ...