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The drugs slowed cognitive decline in clinical trials used for Food and Drug Administration approval by some 25% to 36% over 18 months.

--NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, today announced the filing of a Citizen Petition with the US Food and Drug Administration, seeking the removal of ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Vinay Prasad had a problem ...

The Food and Drug Administration this month asked Sarepta Therapeutics to suspend shipments of its gene therapy Elevidys.

The Food and Drug Administration commissioner reveals what health officials are prioritizing in a forthcoming report on childhood chronic disease.

People are injecting peptides to build muscle, trim fat, and reduce inflammation. Does it work?

WASHINGTON (AP) — The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency.

(Reuters) -The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and longtime Stanford University professor, as the director of the ...

The U.S. Food and Drug Administration (FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational gene therapy trials for limb girdle muscular dystrophy following three ...

Orphan Drug Designation in the European Union (EU) is granted by the EC based on a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products.

The Trump administration wants to onshore drug manufacturing. Technologists are answering the call. Looming threats to the pharmaceutical supply chain have brought fresh attention to onshoring.