FDA clears a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine in patients with degener...
A CDRH Webinar reviews changes made to next generation sequencing guidances.
The Association for Accessible Medicines urges FDA to adopt a case-by-case approach in determining whether a 505(b(2) biologic should be deemed to be ...
FDA accepts for priority review a Pfizer NDA for talazoparib for use in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locall...
FDA grants Ironwood Pharmaceuticals an orphan drug designation for olinciguat (IW-1701) for treating patients with sickle cell disease.
Former Office of New Drugs director John Jenkins joins the Corbus Pharmaceuticals board.
Federal Register notice: FDA corrects a 2/23 notice announcing that Sun Pharmaceutical Industries asked to withdraw its generic benazepril hydrochlori...
FDA rejects Mylan/Biocons biosimilar application for a Lantus follow-on due to manufacturing site questions.