Results 111 to 120 of about 5,351,550 (365)

Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process [PDF]

Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods.
Adrian H. B. Gottschalk, Ernst R. Berndt, Matthew W. Strobeck, Tomas Philipson   +3 more
core  

Inhibition of acyl‐CoA synthetase long‐chain isozymes decreases multiple myeloma cell proliferation and causes mitochondrial dysfunction

Molecular Oncology, EarlyView.
Triacsin C inhibition of the acyl‐CoA synthetase long chain (ACSL) family decreases multiple myeloma cell survival, proliferation, mitochondrial respiration, and membrane potential. Made with Biorender.com. Multiple myeloma (MM) is an incurable cancer of plasma cells with a 5‐year survival rate of 59%.
Connor S. Murphy, Heather Fairfield, Victoria E. DeMambro, Samaa Fadel, Carlos A. Gartner, Michelle Karam, Christian Potts, Princess Rodriguez, Ya‐Wei Qiang, Habib Hamidi, Xiangnan Guan, Calvin P. H. Vary, Michaela R. Reagan   +12 more
wiley   +1 more source

Landmark Alzheimer’s drug approval confounds research community

Nature, 2021
Asher Mullard
semanticscholar   +1 more source

Impact of high-cost drugs for individual patient use [PDF]

, 2004
To document and describe the individual patient use (IPU) scheme at St Vincent's Hospital, Sydney in terms of submissions and approvals and assess the financial impact of the scheme on the hospital drug expenditure.
Brien, JE, Gallego, G, Melocco, T, Taylor, SJ   +3 more
core   +1 more source

Analysis of comprehensive genomic profiling of solid tumors with a novel assay for broad analysis in clinical diagnostics

Molecular Oncology, EarlyView.
In molecular cancer diagnostics, comprehensive genomic profiling (CGP) is going to replace the small NGS panels since it provides all clinically relevant somatic variants as well as genomic biomarkers with clinical value. Here, we compared two CGP assays and demonstrate that the choice for diagnostic implementation will depend on the specific ...
Guy Froyen, Pieter‐Jan Volders, Ellen Geerdens, Severine Berden, Joni Van der Meulen, Aaron De Cock, Stefanie Vermeire, Jacques Van Huysse, Marie de Barsy, Gabriela Beniuga, Wendy W. J. de Leng, Anne M. L. Jansen, Imke Demers, Zeliha Ozgur, Hendrikus Jan Dubbink, Ernst‐Jan M. Speel, Wilfred F. J. van IJcken, Brigitte Maes   +17 more
wiley   +1 more source

Current landscape of clinical development and approval of advanced therapies

Molecular Therapy: Methods & Clinical Development, 2021
Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical ...
Carolina Iglesias-Lopez, Antonia Agustí, Antoni Vallano, Merce Obach   +3 more
doaj  

Dr-COVID: Graph Neural Networks for SARS-CoV-2 Drug Repurposing [PDF]

arXiv, 2020
The 2019 novel coronavirus (SARS-CoV-2) pandemic has resulted in more than a million deaths, high morbidities, and economic distress worldwide. There is an urgent need to identify medications that would treat and prevent novel diseases like the 2019 coronavirus disease (COVID-19).
arxiv  

US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised.

Archives of Pathology & Laboratory Medicine, 2018
April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology.
A. Evans, T. Bauer, M. Bui, Toby C. Cornish, Helena Duncan, E. Glassy, J. Hipp, R. S. Mcgee, Doug Murphy, Charles Myers, D. G. O’Neill, A. Parwani, B. Rampy, M. Salama, L. Pantanowitz   +14 more
semanticscholar   +1 more source

Strong Support For Sununu, Drugs Remain Most Important Problem Facing NH 5/9/17 [PDF]

, 2017
Governor Chris Sununu enjoys bipartisan approval of his job performance as well as increasing personal favorability among New Hampshire adults. A strong majority continue to believe overall the state is headed in the right direction, but for the first ...
Survey Center, UNH
core   +1 more source

Response to neoadjuvant chemotherapy in early breast cancers is associated with epithelial–mesenchymal transition and tumor‐infiltrating lymphocytes

Molecular Oncology, EarlyView.
Epithelial–mesenchymal transition (EMT) and tumor‐infiltrating lymphocytes (TILs) are associated with early breast cancer response to neoadjuvant chemotherapy (NAC). This study evaluated EMT and TIL shifts, with immunofluorescence and RNA sequencing, at diagnosis and in residual tumors as potential biomarkers associated with treatment response.
Françoise Derouane, Jérôme Ambroise, Cédric van Marcke, Mieke Van Bockstal, Martine Berlière, Christine Galant, Hélène Dano, Médina Lougué, Elena Benidovskaya, Guy Jerusalem, Vincent Bours, Claire Josse, Jérôme Thiry, Aurélie Daumerie, Caroline Bouzin, Cyril Corbet, François P. Duhoux   +16 more
wiley   +1 more source