The Food and Drug Administration will miss a deadline this week deciding whether to approve a drug for a potentially ...

A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy ...

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

Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with resectable locally advanced head and neck ...

The U.S. Food and Drug Administration has recalled certain bags of frozen shrimp because of the threat of listeria. The recall was initiated by the Food and Drug Administration (FDA) on June 10.

By Puyaan Singh (Reuters) -KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended ...

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

While some compounding pharmacies have stopped making alternatives to Wegovy and Zepbound since shortages were declared over, ...

Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted ...

SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound healing, today ...

The federal government plans to develop a new definition of ultraprocessed foods, a wide-ranging group of snacks, meals and ...