FDA reminds healthcare facility reprocessing staff to use the correct ASP Sterrad sterilization system decontamination cycle with compatible N95 respi...
FDA approves an Amivas NDA for artesunate for injection 110 mg, powder and solvent for solution, indicated for the initial treatment of severe malaria...
FDA approves a new indication for Astellas VESIcare in an oral suspension to treat a type of bladder dysfunction in pediatric patients over age two.
FDA denies a petition asking it to investigate and take enforcement action against Edwards Lifesciences for marketing an annuloplasty ring without 510...
GlaxoSmithKline submits to FDA additional materials involving an assessment of its Zofran.
FDA accepts for review a Fresenius Kabi BLA for a pegfilgrastim biosimilar candidate (MSB11455) that references Amgens Neulasta.
FDA denies a Public Citizen petition asking it to revoke the PMA approval for Cyberonics Vagus Nerve Stimulation device for use in treating treatment-...
FDA says it will not object to some design or manufacturing modifications for devices approved through a PMA or HDE during the Covid-19 public health ...