The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval ...

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 ...

Lynozyfic (linvoseltamab) has been given accelerated approval by the US regulator for adults with relapsed or refractory ...

The FDA has upgraded Alma Pak’s blueberry recall to the highest risk level following positive tests for Listeria ...

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

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

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

(Reuters) -The U.S. Food and Drug Administration has approved Regeneron's cancer therapy, the company said on Wednesday, ...

Lupin Limited secures FDA approval for Loteprednol Etabonate Ophthalmic Gel, enhancing treatment options for postoperative ...

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