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FDA issues a draft guidance entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry.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 makes available a final guidance entitled Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the...
Federal Register notice: FDA determines that KTAB (potassium chloride) extended-release tablets were not withdrawn due to safety or effectiveness conc...
Federal Register notice: FDA permanently debars Raidel Figueroa from providing services in any capacity to a person that has an approved or pending dr...
Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, which is studying the combination use with a full-dose o...
