FDA accepts for review a Cosmo Pharmaceuticals NDA for Aemcolo (rifamycin SV MMX) for treating patients with travelers diarrhea.
Federal Register notice: FDA publishes a draft guidance on Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.
Federal Register notice: FDA makes available a guidance entitled Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogona...
FDA Review post the Federal Register notices for the week ending 5/18/2018.
FDA posts a guidance on Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorder...
FDA approves an Amgen BLA for Aimovig (erenumab), a once-monthly self-injection for preventing migraines in adults.
FDA publishes a draft guidance on Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.
Medtronic recalls its MindFrame Capture LP revascularization device due to wire material that may break or separate during use.