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

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

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

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

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

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 has approved Moderna’s (NASDAQ:MRNA) RSV vaccine, mRESVIA (mRNA-1345), for preventing ...

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said he told U.S. Senator Bill Cassidy that he would allow ...

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

The Trump administration includes among its criminal targets foreign officials who have received bribes from drug trafficking and organized crime money-laundering networks ...

Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...