The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...

The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a ...

Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...

The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing ...

The global watchdog of doping in sports says it will urge public authorities to shut down the drug-fueled Enhanced Games ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.

(Reuters) -The U.S. Food and Drug Administration has placed a clinical hold on Gilead Sciences' trials testing a combination ...

Sometimes called “gas station heroin,” the products are usually marketed as energy shots or cognitive supplements but ...

The U.S. Food and Drug Administration has rolled out a new AI assistant, Elsa, that it says will increase efficiency at its ...

Generic drugmaker Natco Pharma’s active pharmaceutical igredients (API) manufacturing plant in Mekaguda, Hyderabad, has been issued a Form 483 with one observation by the U.S. Food and Drug ...