Cempra's Solithera Draws FDA Complete Response Letter On Liver Risks
Limited population approval pathway in 21st Century Cures law may not help Cempra overcome US agency's request for new 9,000-patient safety study of the macrolide antibiotic.
Limited population approval pathway in 21st Century Cures law may not help Cempra overcome US agency's request for new 9,000-patient safety study of the macrolide antibiotic.