FDA warns Integra Lifesciences about Quality System Regulation violations in the manufacturing of neurological and neurosurgical medical devices at th...
FDA warns Marlborough, MA-based Hologic about Quality System and Medical Device Reporting violations in its production of implantable radiographic mar...
Federal Register notice: FDA issues Novo Nordisk a priority review voucher for gaining approval for its hemophilia drug Alhemo (concizumab-mtci) last ...
Federal Register notice: FDA withdraws the approval of 12 NDAs from multiple applicants because they are no longer marketed.
The HHS Inspector General raises concerns about three of 24 drugs approved through the FDA accelerated approval pathway.
FDA says a new method of determining an acceptable intake limit for nitrosamine impurities in drugs that it helped to develop has expedited regulatory...
The Association for Accessible Medicines calls on FDA to produce several guidances for generic oligonucleotide drugs.
FDA accepts for review an Eisai BLA for Leqembi (lecanemab-irmb) subcutaneous autoinjector weekly maintenance dosing for treating Alzheimers disease.
