The Latest Breaking News from FDA

It’s August, and parents and caregivers are frantically preparing their kids for a new school year by buying supplies, filling out forms and meeting teachers. This year, many parents also face a question that’s more complicated than usual: Should my child get an updated COVID-19 vaccine, and will I even…

Cognition Therapeutics Inc. (NASDAQ:CGTX) shares jumped 30% to $1.43 in pre-market trading on Wednesday after the company announced FDA confirmation of its Phase 3 trial design for Alzheimer’s drug Zervimesine (CT1812).

On Monday, the U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals, Inc.’s (NASDAQ:AMPH) Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.

Hims Hers Health Inc. (NYSE:HIMS) has been one of 2025’s hottest telehealth stocks, nearly doubling in value year to date, but a deepening clash with Novo Nordisk A/S (NYSE:NVO) over compounded weight-loss drugs, and shifting FDA rules, has turned momentum into headwinds, sending shares sliding 10% in the past three…

When a major pet food recall happens, it often makes national news, sending worried pet owners rushing to check their pantries. However, many smaller recalls issued by the U.S. Food and Drug Administration (FDA) never make the headlines. These quiet recalls can involve products contaminated with dangerous bacteria like Salmonella…

Shares of Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) are trading sharply higher Tuesday morning following the release of the company’s second-quarter financial results and operational update.

Altimmune, Inc. (NASDAQ:ALT) reported its second-quarter financial results before Tuesday’s opening bell.

More than 800 cases of the sugar cookies were recently recalled

For years, certain “health food” products have been promoted as miracle solutions for weight loss, better digestion, and overall wellness. Shoppers stocked their pantries with these items, trusting bold packaging claims and viral endorsements. But behind the scenes, the FDA has quietly shifted its stance on some of these trends—removing…