Washington, DC - A first-time mother’s risk of pelvic floor disorders is strongly associated with how her baby is delivered, according to a study funded by the National Institutes of Health. Pelvic floor disorders are thought to result from weakening or injury of the muscles, ligaments and connective tissue in the lowest part of the pelvis. The study, funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, was led by Victoria Handa, M.D., of Johns Hopkins Bayview Medical Center, Baltimore, and appears in the Journal of the American Medical Association.

Washington, DC - In general, women who have had children have a lower risk of breast cancer compared to women who have never given birth. However, new research has found that moms don’t experience this breast cancer protection until many years later and may face elevated risk for more than 20 years after their last pregnancy.

Washington, DC - African-Americans with moderate or severe sleep apnea are twice as likely to have hard-to-control high blood pressure when their sleep apnea goes untreated, according to a new study funded mainly by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. The findings, which researchers say may partially explain why African-Americans suffer hypertension at rates higher than any other group, point to screening and treatment of sleep apnea as another important strategy for keeping uncontrolled high blood pressure at bay.

Washington, DC - An interim analysis of a large phase 3 clinical trial found that the combination of ibrutinib plus rituximab was superior to standard treatment for patients age 70 and younger with previously untreated chronic lymphocytic leukemia (CLL). The trial met its primary endpoint of an improvement in progression-free survival (the length of time patients live before their disease worsens). The combination also improved overall survival, the trial’s secondary endpoint. In general, patients in the ibrutinib–rituximab arm were less likely to experience serious side effects than those in the standard treatment arm.

Washington, DC - Based on the number of reported cases of AFM in the United States through November 30, 2018, it appears that the number of persons under investigation (PUIs) for AFM has peaked and will continue to decline for the remainder of 2018.

Washington, DC - “The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," said FDA Commissioner Scott Gottlieb, M.D. “At the same time, the FDA is modernizing its 510(k) pathway, which is used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market. The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances.