Food and drug administration

  1. Zuranolone was approved for postpartum depression, not major depressive disorder
    Analysis of zuranolone approval reveals how fast-track designations and reduced evidentiary thresholds in drug regulation may inadequately balance innovation with public health protection.
  2. Turkish drug recalls were driven by contamination, sterility, and safety issues
    Systematic analysis of 133 drug recalls by Turkish regulatory agency 2018-2024, identifying 14 recall reasons with Class A and B classifications predominating.
  3. Meloxicam approval in cats is questioned over kidney risk and missing trial data
    Examine injectable meloxicam approval for cats, regulatory data discrepancies, acute kidney injury risks, and pharmaceutical sponsorship conflicts in veterinary medicine.
  4. FAERS data show post-marketing adverse event patterns with casimersen
    Pharmacovigilance analysis of casimersen adverse event reporting patterns using FAERS database with characterization of preferred terms, organ systems, and time-to-onset distributions.