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

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

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

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

FDA regulators said Thursday that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit ...

The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...

The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...

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

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

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