FDA Committee Does Not Recommend Approval of Aducanumab for Alzheimer Disease
November 9th 2020A final vote that assessed whether the findings from the EMERGE trial served as primary evidence for the efficacy of aducanumab in Alzheimer disease was 10–0 that the trial did not provide evidence.
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New Data Show Oral Semaglutide Significantly Reduced A1C in Adults with Type 2 Diabetes
June 25th 2018Newly published findings from the PIONEER 1 phase 3a trial show that once-daily once-daily oral semaglutide was associated with significant reductions in blood sugar in adults with type 2 diabetes.
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Community Program Improves Diet, Depressive Symptoms Among Latina Mothers
June 23rd 2018A study of another such program—Healthy MOMs, or Mothers on the Move—has shown significant improvements in dietary practices and the incidence of depressive symptoms in Latina mothers at risk for type 2 diabetes.
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Single-Sample Testing May Confirm Diabetes Diagnosis
June 21st 2018While normally a diabetes diagnosis requires multiple sample confirmations from blood work of elevated hemoglobin A1C (HbA1C) or glucose, new data has shown that a single-sample confirmatory diagnosis of diabetes may be possible.
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FDA Approves Treatment for for Chronic Immune Thrombocytopenia
April 19th 2018Officials with the FDA have approved fostamatinib disodium hexahydrate (Tavalisse, Rigel) for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment
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FDA Accepts NDA for Investigational Major Depressive Disorder Therapy
April 16th 2018Officials with the FDA have accepted a new drug application (NDA) for Alkermes once-daily, oral, investigative major depressive disorder (MDD) therapy, ALKS 5461, intended for use in patients with an inadequate response to standard antidepressant treatment.
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