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

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

Overall, just 1 out of 10 drug candidates that gets through animal testing succeeds all the way through clinical trials and gains regulatory approval. AI is helping close the translational gap.

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

“If the question is, can AI replace a human reviewer, I would say absolutely not,” said Jason Conaty, counsel in the Los Angeles office of Hogan Lovells who specializes in drug regulatory affairs.

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

Traditionally, drug discovery relied heavily on trial and error, with long timelines and high costs. The introduction of ...

For decades, Alzheimer’s disease has resisted nearly every significant pharmaceutical intervention. Despite billions invested and a growing aging population, most drug candidates have failed during ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

Drug discovery has long been criticized for its slow, costly, and failure-prone nature. Traditional approaches, particularly ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...