The U.S. Food and Drug Administration (FDA) on Monday named seven companies selected for its FDA PreCheck Pilot Program. The ...

FDA names companies domestic drug manufacturing pilot participants to enhance early regulatory engagement and streamline review processes.

An independent research firm is reviewing data on Amgen’s Tavneos as the company prepares for a hearing with the FDA which could determine whether the rare disease treatment remains on the market. In ...

June 3 (Reuters) - The U.S. FDA's Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for an artificial intelligence-based drug development tool designed to ...

In April, the FDA debuted a real-time clinical trial model that will allow the agency to monitor safety signals as the trial is being conducted. The first trials were launched in partnership with ...

Dr. Tracy Beth Høeg is leaving her role as head of the FDA division that regulates over-the-counter and prescription drugs, according to a Department of Health and Human Services official. Limited ...

An experimental drug that could be a breakthrough in the treatment of one of the deadliest known cancers is driving demand at clinics while awaiting full government approval. Daraxonrasib, a drug that ...

Olivia Rinaldi is a White House reporter at CBS News. She covered President Trump's 2024 presidential campaign and was previously an associate producer for "CBS Evening News with Norah O'Donnell" and ...

If your Mac's storage has been mysteriously shrinking recently and you use Google Chrome, you may have already identified the culprit. The browser has been downloading a 4GB AI model file onto ...

With an FDA decision date looming for its Duchenne muscular dystrophy (DMD) treatment deramiocel, Capricor Therapeutics has filed a lawsuit against its commercial partner in the United States, NS ...

National Economic Council Director Kevin Hassett said Wednesday the White House is considering an executive order that would require AI models to go through an evaluation process similar to that used ...