FDA clears a Cagent Vascular 510(k) for its Serranator PTA Serration Balloon Catheter for treating below-the-knee lesions.
FDA publishes a temporary policy on repackaging or combining propofol general anesthesia products to help ease a shortage during the Covid-19 public h...
ProPharma Group lists steps drug companies can take to best handle planned and unplanned internal and external inspections.
Four stakeholders say they support an FDA reclassification of some HIV tests to Class 2 with special controls.
FDA grants Baxter International an emergency use authorization for the Oxiris filter set to treat patients who have confirmed Covid-19 and have been a...
CNS Pharmaceuticals seeks an FDA orphan drug designation for berubicin for treating glioblastoma.
Kaiser Health News says FDA has increased seizures of drugs being imported into the U.S. from Canada and other countries by individual consumers.
FDA says Trividia Health is recalling a single True Metrix Air blood glucose meter that has an incorrect factory-set unit of measure.