The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...

Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and ...

The FDA's generative AI, Elsa, has a massive hallucination problem, according to the agency's employees themselves.

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

You'll get access to an ad-free website with a faster photo browser, the chance to claim free tickets to a host of events ...

The East Baton Rouge Metro Council approved to increase higher fines and penalties to businesses and bars who serve alcohol to minors. The age range decreases to 17 and under.

The mind-expanding drugs may help heal many mental health conditions. But studies haven’t actually proved that yet.

An FDA panel meeting featured a heated dialogue over whether fluoride supplements could pose health risks to children. Here's ...

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...

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