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On Sept. 1, the U.S. Food and Drug Administration (FDA) approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML) and for he treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or are refractory to initial treatment. Continue reading
August 3, 2017 – The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more. Continue reading
Cadmium exposure and endometrial cancer risk: A large midwestern U.S. population-based case-control study.
Estrogen-mimicking chemicals, such as cadmium, may be associated with increased susceptibility to hormone-dependent cancers, though supporting data are sparse, particularly for endometrial cancer. The Health and Environmental Exposure Research (HEER) study worked with the Arkansas Central Cancer Registry, Iowa Cancer Registry and Missouri Cancer Registry to obtain names of women diagnosed with endometrial cancer who were willing to be contacted for participation in our case control study. Continue reading
August 3, 2017 – The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
cGVHD is a life-threatening condition that can occur in patients after they receive a stem cell transplant from blood or bone marrow, called hematopoietic stem cell transplantation (HSCT), to treat certain blood or bone marrow cancers. cGVHD occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues. Symptoms of cGVHD can occur in the skin, eyes, mouth, gut, liver and lungs. The condition is estimated to occur in 30-70 percent of all patients who receive HSCT. Continue reading
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
Remarks by Scott Gottlieb, M.D. / Commissioner of Food and Drug Administration
July 28, 2017 / White Oak, MD
Tobacco use remains the leading cause of preventable disease and death in the United States. But much has changed in the landscape of tobacco product regulation and FDA’s ability to address this public health crisis.
For one, FDA has significant new regulatory authorities. When I last served, FDA lacked the authority to regulate tobacco products as traditionally marketed. Since that time, our statute has been amended to include an entire chapter of new authorities. And FDA has stood up a new Center for Tobacco Products that already has a number of important accomplishments. Continue reading
Pneumonia or sepsis in adults associated with increased risk of cardiovascular disease.
Sophia Antipolis, 2 August 2017: Pneumonia or sepsis in adults that results in hospital admission is associated with a six-fold increased risk of cardiovascular disease in the first year, according to research published today in the European Journal of Preventive Cardiology.(1) Cardiovascular risk was more than doubled in years two and three after the infection and persisted for at least five years. Continue reading
By Ashleigh Anderson, BSN, RN, PCCN, and Amanda Swedhin, BSN, RN, CMSRN
By Timothy P. Luckett, CRNFA