Tag: Food and drug administration
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.
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.
