A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants ...

Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood ...

Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood ...

Dr. George Tidmarsh, physician, scientist, and biotech CEO, joins Jerry Rogers on "The Business of America" podcast to ...

Aldeyra's Reproxalap progresses towards FDA approval, with a potential $100M AbbVie deal. There’s still upside potential, ...

While both the Novavax vaccine and the newest generation of the mRNA Moderna vaccines had been signed off on by about 30 FDA vaccine officials, Prasad ended up writing overrides for each, restricting ...

The FDA cleared an artificial intelligence (AI)-powered wristband (Felix NeuroAI) to treat upper-limb functional limitations ...

The safety update for Vyvgart rattled argenx’s shares on Monday, a reaction that analysts at William Blair said was “overdone ...

The FDA designates the TOBY Test as a breakthrough device, revolutionizing bladder cancer detection with a non-invasive, ...

A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason. Now his ...