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

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but ...

The '80s were a time of unique food products and diet trends, but these eyebrow-raising food safety issues just weren't top ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting ...

But it’s unclear if the evidence provided to support continued use of fluoridated supplements will matter. The FDA said in ...

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

By Kingsley Webora TANKEH Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and medium-sized enterprises (SMEs) from obtaining the ...

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater than currently accepted.

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...