The U.S. Food and Drug Administration has declined to approve PTC Therapeutics' drug to treat a rare genetic disorder with ...

The U.S. Food and Drug Administration placed a clinical hold on a study of BiomX's cystic fibrosis treatment in order to review data on the third-party nebulizer used to deliver the drug. Patient ...

The U.S. Food and Drug Administration has turned away PTC Therapeutics' proposed vatiquinone treatment for the rare, inherited neurodegenerative disorder Friedreich's ataxia over concerns about the ...

When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert ...

The FDA and Fromi USA recalled Brie cheese wheels sold in New York because they could be contaminated with Listeria, an ...

The glucagon-like peptide-1 (GLP-1) receptor agonist gained accelerated approval for patients with MASH and moderate to ...

The FDA said in letters to five sunscreen makers that they are not authorized to market sunscreen sold in mousse or whipped form.

US regulators sent seemingly mixed messages this month about the outlook for animal-derived, or desiccated, thyroid medicines ...

By Lori Solomon HealthDay ReporterMONDAY, Aug. 18, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

The FDA’s recent issue of five warning letters to brands illegally marketing whipped, mousse and foam sunscreen products ...

Sublingual cyclobenzaprine (Tonmya), a nonopioid treatment for adults with fibromyalgia, targets nonrestorative sleep, a root ...

FDA proposes lowering the orange juice Brix standard from 10.5% to 10.0%, reducing costs, boosting U.S. citrus use, and ...