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 approved UroGen Pharma's drug to treat a type of bladder cancer, providing ...

(Reuters) -The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus ...

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

Moderna said the Food and Drug Administration expanded its approval of the pharmaceutical company's respiratory syncytial virus vaccine, mResvia, to adults aged 18-59 at increased risk for the disease ...

Keytruda was approved for locally advanced head and neck cancer before and after surgery, showing improved event-free ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump ...

The U.S. Food and Drug Administration has approved George Medicines' Widaplik (telmisartan, amlodipine, and indapamide) for ...

But there are limits. Some FDA staff said Elsa often gave wrong answers and has to be double-checked. Others said the tool ...

With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...

Agency’s new road map aims for faster approvals and healthier food, but some experts caution AI is not yet up to the task.

The federal government plans to develop a new definition of ultraprocessed foods, a wide-ranging group of snacks, meals and ...