The FDA underwent significant changes during the first year of the second Trump administration, directly affecting business ...

On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the ...

Key Takeaways On Feb. 6, 2026, FDA announced that it would take action to restrict access to GLP-1 ingredients for non-FDA ...

The U.S. Food and Drug Administration (FDA) released its Human Foods Program (HFP) 2026 Priority Deliverables on January 23, outlining a broad set of regulatory initiatives for the year ahead. FDA’s ...

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the fight between Novo Nordisk and Hims & Hers over GLP-1 drugs, immunization policies in the U.S., and more.

The Food and Drug Administration (FDA) on Friday conducted coordinated compliance verification visits to major retail ...

FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...

A recent pilot offers business leaders a strategic case study on how regulatory sandboxes can enable infrastructure ...

The U.S. Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of ...

Eli Lilly has secured approvals from the FDA and the European Medicines Agency (EMA) for Alzheimer’s disease drug Kisunla, but the company is striking out with regulators in the U.K. For a second time ...

After keeping the faith when it failed in the Modify phase III trial in October 2021, Idorsia Ltd. now has a clear route to market for lucerastat, an oral therapy for Fabry disease.