KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended the review of its drug for 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 expanded the use of Moderna's respiratory syncytial virus vaccine to a ...

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 ...

Sun Pharma bagged eight observations from the US-based regulatory agency US FDA, following an observation at its Halol plant ...

Sun Pharma said the US FDA issued a Form-483 with eight observations after inspecting its Halol facility from June 2–13.

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

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

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

THE US Food and Drug Administration (US FDA) officially approved Nutriasia's petition to remove Mang Tomas All Purpose Sauce, ...

The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the ...