News

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
FDA panel on the use of antidepressants during pregnancy is alarming experts
On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications ...
The FDA Just Axed 52 Food Standards. Is That a Good Thing?
It noted that, at the time, there were products "that were represented as jams containing fruit, but the products contained ...
FDA to review prescription fluoride supplements for kids at risk for tooth decay
The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...
BioSpace3h
FDA Opens Pilot Run of Commissioner Voucher Program
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
FoodNavigator-USA2h
FDA’s 2025 Food Agenda: What industry must know
Explore the FDA’s 2025 Human Foods Program Guidance Agenda and what it means for US food and beverage businesses. Key ...
Healio2h
FDA accepts reproxalap new drug application for dry eye disease again
The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry ...
FDA appoints George Tidmarsh as top drug regulator
The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...
FDA Issues Risk Warning for Bread Recall Update
The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary ...
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
FDA Names Former Pharmaceutical Company Executive to Oversee US Drug Program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...