FDA approves a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression in adults.
FDA issues a draft guidance entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry.
FDA approves an Astellas Pharmas Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy secondary to age-related macular d...
FDA clears an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts.
Federal Register notice: FDA determines that Cubist Pharmaceuticals Cubicin and Cubicin RF (daptomycin) powder for injection were not withdrawn due to...
Federal Register notice: FDA seeks comments concerning abuse potential and the impact of scheduling changes on availability for medical use of eight d...
Federal Register notice: FDA makes available a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Imp...
Drgerwerk recalls its Drger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas.
