Results 61 to 70 of about 1,709,620 (289)

An insider's perspective on FDA approval of aducanumab

Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 2023
Introduction Aducanumab was approved in 2021 by the US Food and Drug Administration (FDA) under the accelerated approval pathway. Since then, there have been many misconceptions about the approval decision despite multiple publications from the FDA to ...
Yaning Wang
doaj   +1 more source

Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs

EClinicalMedicine, 2020
Background: In July 2018, the FDA first published a table listing all surrogate measures that it has used, and may accept for future use, in regulatory approval. However, the strength of surrogacy for those measures was not formally assessed.
Bishal Gyawali, Spencer P. Hey, Aaron S. Kesselheim   +2 more
doaj   +1 more source

Alterations in the self-renewal and differentiation ability of bone marrow mesenchymal stem cells in a mouse model of rheumatoid arthritis [PDF]

, 2010
Introduction: Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease primarily involving the synovium. Evidence in recent years has suggested that the bone marrow (BM) may be involved, and may even be the initiating site of the disease ...
Bellantuono, I., Coulton, L., Croucher, P.I., Gambardella, A., Hughes, D., Kottam, L., Mohanty, S.T., Nicklin, M.J., Wilson, A.G.   +8 more
core   +3 more sources

A correlation analysis to assess event-free survival as a trial-level surrogate for overall survival in early breast cancer

EClinicalMedicine, 2021
Background: Event-free survival (EFS) has been listed on the FDA Table of Surrogate Endpoints as a surrogate measure that can be considered for accelerated or traditional approval in breast cancer.
Bishal Gyawali, Elvira D'Andrea, Jessica M. Franklin, Aaron S. Kesselheim   +3 more
doaj   +1 more source

The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]

, 2018
Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D, Ferrell, Andrea, Hsiung, Andre, Humphries, Romney M, Kircher, Susan, Krause, Kevin M, Malherbe, Rianna   +6 more
core   +2 more sources

Accelerating vaccine development and deployment: report of a Royal Society satellite meeting. [PDF]

, 2011
The Royal Society convened a meeting on the 17th and 18th November 2010 to review the current ways in which vaccines are developed and deployed, and to make recommendations as to how each of these processes might be accelerated.
Bregu, Migena, Draper, Simon J, Greenwood, Brian M, Hill, Adrian VS   +3 more
core   +2 more sources

Accelerated Approval for Cancer Drugs in the United States and the Clinical Evidence Required for Conversion to Regular Approval

Journal of Pharmaceutical Innovation
Oncology products often leverage accelerated approval program to seek earlier launches in the United States. Little is known about how the Food and Drug Administration (FDA) has been balancing evidence and access, and the factors that may characterize ...
Satoshi Kato, Shunsuke Ono
semanticscholar   +1 more source

Ethical Issues in the Drug Approval Process [PDF]

, 2013
The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for ...
McInnis, Meghan
core   +1 more source

Organoids in pediatric cancer research

FEBS Letters, EarlyView.
Organoid technology has revolutionized cancer research, yet its application in pediatric oncology remains limited. Recent advances have enabled the development of pediatric tumor organoids, offering new insights into disease biology, treatment response, and interactions with the tumor microenvironment.
Carla Ríos Arceo, Jarno Drost
wiley   +1 more source

Mitochondrial fatty acid oxidation is stimulated by red light irradiation

FEBS Letters, EarlyView.
Light at different wavelengths has distinct effects on keratinocyte viability and metabolism. UVA light abrogates metabolic fluxes. Blue and green light have no effect on metabolic fluxes, while red light enhanced oxidative phosphorylation by promoting fatty acid oxidation. Keratinocytes are the primary constituents of sunlight‐exposed epidermis.
Manuel Alejandro Herrera, Camille C. Caldeira da Silva, Maiza Von Dentz, Mauricio S. Baptista, Alicia J. Kowaltowski   +4 more
wiley   +1 more source