Results 81 to 90 of about 731,751 (310)

Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program [PDF]

, 2021
Cheryl Ho, Howard J. Lim, Dean A. Regier
openalex   +1 more source

US Food and Drug Administration

The Palgrave Encyclopedia of Interest Groups, Lobbying and Public Affairs, 2021
Barbara Desanto
semanticscholar   +1 more source

Berberine–cinnamic acid co‐crystal effect in ameliorating hyperlipidemia might be regulated through the PI3K/AKT/mTOR/SREBP‐1 signaling pathway

FEBS Open Bio, EarlyView.
Berberine–cinnamic acid co‐crystal (BBR‐CA) inhibits the phosphorylation of the phosphatidylinositol 3‐kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) pathway, suppressing the transfer of pre‐sterol regulatory element‐binding proteins‐1 (SREBP‐1) from the endoplasmic reticulum to the nucleus. This results in a decrease in the expression level of
Wenheng Gao, Yunlong Li, Lihua Chen, Wenshuo Yang, Yong He, Ye Yang, Dengke Yin, Song Tan   +7 more
wiley   +1 more source

Interplay between RNA‐protein interactions and RNA structures in gene regulation

FEBS Open Bio, EarlyView.
Methodological advances in mapping transcriptome‐wide RNA‐protein interactions and RNA structures have started to uncover the potential of RNP conformations in gene regulation. Competing RNA–RNA, RNA‐protein and protein–protein interactions shape the compaction and function of RNPs throughout their lifetime and may provide novel therapeutic targets in ...
Jenni Rapakko, Mauro Scaravilli, Minna‐Liisa Änkö   +2 more
wiley   +1 more source

Public feedback to FDA on regulatory considerations for AI in drug manufacturing

AAPS Open
FDA’s Center for Drug Evaluation and Research (CDER) established the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to establish a regulatory framework to support the adoption of advanced manufacturing technologies that ...
Jayanti Das, Thomas F. O’Connor, Adam C. Fisher, Manuel Osorio, Johnny Lam, Riley C. Myers   +5 more
doaj   +1 more source

Day/night variations of myeloid and lymphoid cell subsets in the murine inguinal lymph node

FEBS Open Bio, EarlyView.
The circadian system is involved in the temporal regulation of the immune system. Our study reveals that two innate immune populations, NKT cells and neutrophils, predominate at the beginning of the day in healthy mice, highlighting how the time of day influences immune responses.
Paula M. Wagner, César G. Prucca, Lucia Boffelli, Virginia A. Piqueras, Silvia G. Correa, Mariana Maccioni, Mario E. Guido   +6 more
wiley   +1 more source

Injection-Site Nodules Associated With the Use of Exenatide Extended-Release Reported to the U.S. Food and Drug Administration Adverse Event Reporting System

Diabetes Spectrum, 2015
Glucagon-like peptide-1 (GLP-1) receptor agonists are safe and effective U.S. Food and Drug Administration (FDA)-approved drug products for use in the treatment of type 2 diabetes.
S. Jones, Debra L. Ryan, Valerie Pratt, A. Niak, A. Brinker   +4 more
semanticscholar   +1 more source

Influenza A virus hemagglutinin mutations associated with use of neuraminidase inhibitors correlate with decreased inhibition by anti-influenza antibodies

Virology Journal, 2019
Background Vaccination and the use of neuraminidase inhibitors (NAIs) are currently the front lines of defense against seasonal influenza. The activity of influenza vaccines and antivirals drugs such as the NAIs can be affected by mutations in the ...
Natalia A. Ilyushina, Takashi E. Komatsu, William L. Ince, Eric F. Donaldson, Nicolette Lee, Julian J. O’Rear, Raymond P. Donnelly   +6 more
doaj   +1 more source

Additively manufactured medical products – the FDA perspective

3D Printing in Medicine, 2016
Additive manufacturing/3D printing of medical devices is becoming more commonplace, a 3D printed drug is now commercially available, and bioprinting is poised to transition from laboratory to market.
Matthew Di Prima, James Coburn, David Hwang, Jennifer Kelly, Akm Khairuzzaman, Laura Ricles   +5 more
doaj   +1 more source

ATG4B is required for mTORC1‐mediated anabolic activity and is associated with clinical outcomes in non‐small cell lung cancer

FEBS Open Bio, EarlyView.
The relationship between anabolic and catabolic processes governing lung cancer cell growth is nuanced. We show that ATG4B, an autophagy regulator, is elevated in lung cancer and that high ATG4B is associated with worse patient outcomes. Targeting ATG4B in cells reduces growth, protein synthesis, and mTORC1 activity, demonstrating a new relationship ...
Patrick J. Ryan, Bethany C. Guerra, Selina Uranga, Jessica M. Cardin, Steven E. Riechman, Mariana Janini Gomes, James D. Fluckey   +6 more
wiley   +1 more source