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

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

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

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

Fuentes Farms LLC., located in McAllen, is recalling 71 boxes of fresh cucumbers due to potential contamination with ...

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 ...

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