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

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 on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a ...

Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could ...

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.

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

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