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 ...

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

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

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

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

AI was supposed to boost drug discovery, but progress has stalled. Learn why the hype hasn’t delivered and what needs to ...

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

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

Introduction. On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the ...

“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.

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 ...