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FDA staff review recommends against Novartis heart failure drug
"We recommend that serelaxin not be approved at this time because there is insufficient evidence to support the proposed indication to "improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure," the report ...
FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug
FDA Rejects Approval of Novartis drug Serelaxin for Heart Failure
FDA Staff Recommends Against Approval For Novartis' Heart-failure Drug ...