FDA approves an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) Linzess (linaclotide) to treat functional constipation in pediatri...
Federal Register notice: FDA seeks comments on an information collection extension on voluntarily submitted medical device regulatory misconduct alleg...
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.
