The NDIN review process follows the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requirement that manufacturers and ...

The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the ...

Yesterday, the New York Times reported that the FDA, in collaboration with USDA and other government agencies, plans to ...

The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...

MENLO PARK, Calif., June 16, 2025 (GLOBE NEWSWIRE) -- Inquis Medical, the leading innovator in the treatment of venous ...

Trump health officials signal eased FDA rules for rare disease gene therapy, but concerns linger over safety, oversight, and ...

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

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

AD04 is Adial's lead investigational drug, a serotonin-3 receptor antagonist, being developed for the treatment of Alcohol ...

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

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...