Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.
Sign Up to like & getrecommendations! Published in 2017 at "Blood"
DOI: 10.1182/blood-2017-04-742726
Abstract: The US Food and Drug Administration (FDA) negotiates the evidence necessary for drug approval with pharmaceutical sponsors. The resulting data package submitted in support of approval includes labeling that conveys the benefits and risks of… read more here.
Keywords: flexibility innovation; innovation fda; novel regulatory; fda novel ... See more keywords
Molecular analysis of human Ero1 reveals novel regulatory mechanisms for oxidative protein folding
Sign Up to like & getrecommendations! Published in 2018 at "Life Science Alliance"
DOI: 10.26508/lsa.201800090
Abstract: This study reveals novel regulatory mechanisms for human Ero1α and Ero1β, including cooperativity for oxygen binding and complex formation with PDI via a novel mixed disulfide linkage. Oxidative protein folding in the ER is driven… read more here.
Keywords: protein; ero1; reveals novel; human ero1 ... See more keywords
The Novel Regulatory Role of the lncRNA–miRNA–mRNA Axis in Chronic Inflammatory Airway Diseases
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Molecular Biosciences"
DOI: 10.3389/fmolb.2022.927549
Abstract: Chronic inflammatory airway diseases, characterized by airway inflammation and airway remodelling, are increasing as a cause of morbidity and mortality for all age groups and races across the world. The underlying molecular mechanisms involved in… read more here.
Keywords: inflammatory airway; novel regulatory; airway; airway diseases ... See more keywords