GlaxoSmithKline says it will seek approval for Nucala (mepolizumab) for treating patients living with Hypereosinophilic Syndrome based on just-announc...
Federal Register notice: FDA announces a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for regulatory decision mak...
Federal Register notice: FDA sends to OMB an information collection extension for Product Jurisdiction: Assignment of Agency Component for Review of P...
FDA warns Mylan about significant deviations from CGMP requirements for active pharmaceutical ingredients at its Unit 8 in India.
FDA warns Indias Cadila Healthcare about CGMP violations in its manufacturing of finished pharmaceuticals.
Becton Dickinson files a PMA supplement for an expanded version of its BD Onclarity HPV Assay.
FDA approves a Hologic PMA for its 3DQuorum Imaging Technology for use with the companys Clarity HD high resolution imaging technology to reduce tomos...