FDA approves Ipsens Bylvay (odevixibat) for an expanded use treating cholestatic pruritus in patients aged 12 months and older with Alagille syndrome...
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...
FDA reviewers recommend that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the XBB-lineage variant...
Federal Register notice: FDA sends to OMB an information collection extension entitled Adverse Event Program for Medical Devices.
