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

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 expanded the use of Moderna's respiratory syncytial virus vaccine to a ...

The global watchdog of doping in sports says it will urge public authorities to shut down the drug-fueled Enhanced Games ...

In a filing made public on Saturday, the company said the inspection concluded with the U.S. regulator issuing Form 483, ...

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

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

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

Learn more about the generative AI technology that will be used at the Food and Drug Administration (FDA) to speed up reviews ...

According to a regulatory filing by the company, the US FDA conducted a Good Manufacturing Practices (GMP) inspection at the ...

Layoffs at the FDA, USDA and CDC could erode the U.S. food safety system. Experts aren’t so worried about milk or chicken today; they’re concerned about the future.

The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of ...