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

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

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

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

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 ...

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

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

Labels of all extended-release stimulants indicated for ADHD -- including certain formulations of amphetamine and ...

A recall was announced after bacteria were found that could cause serious adverse health consequences or death.

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

Sabores Fit Bakery recalled a variety of its mousse desserts on June 20 because of the undeclared presence of allergens.

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