By Puyaan Singh (Reuters) -KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended ...

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

A new drug is helping families who've spent years padlocking fridges, chaining garbage cans, and hiding food as their ...

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." ...

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

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

Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after ...

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

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