Federal Register notice: FDA announces a 5/11 joint Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee meeting...
Bloomberg News says criminal charges are expected to be filed against at least two generic drug companies as part of a price-fixing investigation.
PixarBio CEO Frank Reynolds and two associates are charged with securities fraud.
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.