The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in adults with alkaptonuria, Cycle Pharmaceuticals announced on Thursday. Alkaptonuria is an ultra-rare ...

The FDA announced the recall on June 18, 2025, affecting specific lot codes distributed nationwide. Consumers with milk allergies face serious health risks if they consume these products.

The FDA classified the recall as a Class II, which is defined as "a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health ...

Summer is just around the corner and ice cream is the quintessential warm weather treat. But if you have a carton or two chilling in your freezer, you might want to check the label. Breyers recently ...

The FDA has extended its review of Incyte’s supplemental New Drug Application (sNDA) for ruxolitinib cream 0.75% (Opzelura) for the treatment of mild to moderate atopic dermatitis (AD) in children ...

The FDA approved the use of Cycle Pharmaceuticals’ oral drug nitisinone on Thursday. The product will be marketed under the brand name Harliku, for use in adult patients with alkaptonuria. Affecting ...

The U.S. Food and Drug Administration (FDA) assigned its second most serious risk level, Class II, to a recall of Topo Chico mineral water, owned by The Coca-Cola Company, following the ...

Where was the recalled Breyers ice cream sold? The recalled ice cream was sold at retail locations and distribution centers across the U.S., the FDA said. A total of 6,668 cases were distributed.

Neuspera Medical announced today that the FDA approved its integrated sacral neuromodulation (iSNM) system. The FDA cleared the system for the treatment of urinary urge incontinence (UUI). San ...

The recall includes approximately 6,668 cases of 1.5-quart tubs of Rocky Road ice cream, distributed to retail locations and distribution centers across the United States, according to the FDA.