KVK Tech recalls two lots of atovaquone oral suspension, USP 750 mg/5mL based on customer complaints of unusual grittiness in the product.
FDA accepts for review two Merck supplemental BLAs for its anti-PD-1 therapy Keytruda (pembrolizumab) one for patients with renal cell carcinoma and ...
FDA warns Chinas Lepu Medical Technology it is marketing unapproved Covid-19 test kits in the U.S.
Attorney Patricia Kaufman says many stakeholders will be disappointed by the approach FDA has taken in its new intended use final rule.
FDA clears a Boston Scientific 510(k) for its Exalt Model B Single-Use Bronchoscope, designed for use in bedside procedures within the intensive care ...
FDA clears a SpinTech 510(k) for its Stage magnetic resonance imaging software.
Federal Register notice: FDA makes available a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastas...
Federal Register notice: FDA makes available a final guidance entitled Development and Submission of Near Infrared Analytical Procedures.