The U.S. Food and Drug Administration has approved Urogen Pharma's drug to treat a type of bladder cancer, the regulator said ...

Gentle on aging skin and powerful on persistent breakouts, this new pharmaceutical option is perfect for women battling ...

The FDA approved intravesical mitomycin in non–muscle-invasive bladder cancer as an nonsurgical alternative to transurethral ...

The U.S. Food & Drug Administration (FDA) has issued a recall for 44,550 pounds of Bornstein Seafoods frozen shrimp. The ...

Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”)[1], issued on May 29, 2025, to Sprout ...

The FDA has approved Widaplik, a triple-drug combination, for the treatment of hypertension in adults.

But there are limits. Some FDA staff said Elsa often gave wrong answers and has to be double-checked. Others said the tool ...

Sprout Pharmaceuticals is once again under fire from the FDA’s Office of Prescription Drug Promotion (OPDP). | Sprout ...

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

The Food and Drug Administration has approved a new drug from Merck designed to protect infants from respiratory syncytial ...

Federal regulators have launched a comprehensive review of the ingredients in baby formula — the first deep look at the ...

FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s ...