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Home » FDA Panel Narrowly Recommends Approval of Cempra’s Pneumonia Antibiotic
FDA Panel Narrowly Recommends Approval of Cempra’s Pneumonia Antibiotic
An FDA advisory committee has narrowly backed the approval of Cempra’s antibiotic Solithera for the treatment of community-acquired bacterial pneumonia, despite raising concerns about the candidate’s safety profile and study sample size.