Federal Register notice: FDA announces a 7/12 Oncologic Drugs Advisory Committee meeting to review a Novartis BLA for tisagenlecleucel-T suspension fo...
Women in an Essure Problems advocacy group fault FDA for not doing more to be sure women understand the risks associated with Bayers Essure sterilizat...
Federal Register notice: FDA announces a 7/17 public workshop on developing certain rabies monoclonal antibody products.
Federal Register notice: FDA announces a 7/11 Oncologic Drugs Advisory Committee meeting on Wyeths Mylotarg (gemtuzumab ozogamicin).
FDA cautions against using unapproved versions of Juvederm dermal filler sold online.
FDA asks Endo to pull its Opana ER from the market after determining that the opioid reformulations benefits no longer outweigh its risks.
FDA approves a Qiagen PMA supplement for QuantiFeron-TB Gold Plus, a fourth generation blood test for detecting latent tuberculosis infection.
FDA removes a clinical hold to allow Inovio Pharmaceuticals to begin a Phase 3 study to evaluate the efficacy of its DNA-based immunotherapy, VGX-3100...