The Latest Breaking News from the US Food and Drug Administration

320 gallons of the fat-free milk were affected by the recall

At least five families say their babies were treated for infant botulism after consuming ByHeart formula months before a current outbreak was detected

On Friday, the U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals Holding Corp.’s (NASDAQ:TNXP) Tonmya (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults.

Novartis AG (NYSE:NVS) on Monday released topline data from two Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2, evaluating ianalumab (VAY736) in adults with active Sjögren’s disease.

In a stunning reversal, Dr. Vinay Prasad is returning to his role as director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), just days after his resignation.

Personal care products are part of daily life. You use them to clean, moisturize, and protect your body. But not every product on store shelves is safe everywhere. Some countries have banned certain personal care products because of health risks. These bans might surprise you, especially if you use these…

The US Food and Drug Administration recently convened a panel of experts to examine a sensitive and increasingly urgent question: should antidepressants be prescribed to women suffering from depression during pregnancy?

Eduard Yusupov and Diana Fuzailov sold sexual enhancement products online via their company Love Potion, Inc., claiming them to be made from natural ingredients

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company’s response? A resounding “no,” igniting a major…