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 ...

FDA issues Class I recall for organic blueberries due to Listeria risk. Learn which batches are affected and how to stay safe ...

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 ...

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

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

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

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

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

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

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