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In a first, the FDA has approved an inhibitor of hypoxia-inducible factor-2α. The drug is also the first approved to treat von Hippel-Lindau disease-associated renal cell carcinoma, central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors.
View Article and Find Full Text PDFGenomic and Phylogenetic Analysis of Zika Virus Isolates from Asymptomatic Blood Donors in the United States and Puerto Rico, 2016.
Am J Trop Med Hyg
April 2020
Division of Emerging and Transfusion Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Silver Spring, Maryland.
Zika virus (ZIKV) caused a public health threat in the United States in 2016, leading to rapid development and implementation of blood screening assays for ZIKV RNA. Several ZIKV sequences from clinical cases have been reported, but none from asymptomatic/pre-symptomatic infections. We isolated and sequenced ZIKV from asymptomatic/pre-symptomatic blood donor (ABD-ZIKV) samples and compared with reported clinical sequences.
View Article and Find Full Text PDFUse of Monocyte-Derived Macrophage Culture Increases Zika Virus Isolation Rate from Human Plasma.
Viruses
November 2019
Laboratory of Emerging Pathogens (LEP), Division of Emerging Transfusion Transmitted diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Viral isolation is desirable for many reasons, including development of diagnostic assays and reference materials, and for virology basic research. Zika virus (ZIKV) isolation from clinical samples is challenging, but isolates are known to infect various cell lines. Here, we evaluated suitability of Vero, C6/36 and JEG-3 as host cells, for direct isolation of ZIKV from human plasma.
View Article and Find Full Text PDFWith new safety measures in place, the U.S. Food and Drug Administration will allow Ariad Pharmaceuticals to resume marketing Iclusig, sales of which were suspended in October 2013.
View Article and Find Full Text PDFFDA OK's two drugs for irritable bowel syndrome. The arsenal of IBS drugs is growing, but diagnosis is tricky.
Health News
October 2002
Section of Gastroenterology, Temple University Hospital, Philadelphia, Pennsylvania, USA.
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