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

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

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

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

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

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.

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 ...

(Reuters) -The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV treatments due to low levels of a type of white blood cell in ...

U.S. drug companies are increasingly licensing experimental medicines invented by Chinese firms. Recent deals could be worth ...