BearCare recalls it rechargeable Walnut Wearable Smart Thermometer due to reports about skin burns and irritation.
FDA accepts for review a Phathom Pharmaceuticals NDA resubmission for vonoprazan, a potassium-competitive acid blocker to treat erosive gastroesophage...
FDA clears a GE HealthCare 510(k) for the Sonic DL a deep learning-based technology designed to dramatically accelerate image acquisition in magnetic...
FDA approves a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin and the companys plan to scale up its drug substance m...
Federal Register notice: FDA posts a final guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.
Federal Register notice: FDA announces the renewal of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years.
Federal Register notice: FDA issues an order to permanently debar Analay Rico from providing services in any capacity related to an approved or pendin...
A group of bipartisan senators introduce the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (ALS/Lou Gehrigs Disea...