FDA begins a post-marketing safety evaluation of Acadia Pharmaceuticals Parkinsons drug Nuplazid (pimavanserin) based on safety reports, including 700...
FDA approves a Hologic PMA for the ThinPrep Integrated Imager for automated imaging of Pap tests.
Saranas files a de novo classification for the Early Bird Bleed Monitoring System, a device for use during endovascular procedures to detect the onset...
A Supreme Court decision in an energy company patent case may result in continued use of inter partes review by companies challenging biologics patent...
Bayer sends FDA an updated Essure study interim postmarket surveillance report.
FDA commissioner Scott Gottlieb tells Senate appropriators that the Trump Administrations proposed fiscal year 2019 budget increase of $663 million (1...
Attorney Jennifer Thomas describes actions taken by the Supreme Court in two False Claims Act cases affecting FDA-regulated products.
FDA cautions healthcare providers that magnetic resonance-guided laser interstitial thermal therapy devices may give inaccurate temperature readings, ...