Results 31 to 40 of about 9,077,301 (404)

Ten‐Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs

Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease, 2020
Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals.
M. Khan, Izza Shahid, T. Siddiqi, Safi U. Khan, Haider J. Warraich, S. Greene, J. Butler, E. Michos   +7 more
semanticscholar   +1 more source

BRAF and MEK inhibitors differentially affect nivolumab-induced T cell activation by modulating the TCR and AKT signaling pathways

OncoImmunology, 2019
Immune checkpoint inhibitors (ICIs) such as the anti-PD-1 antibody Nivolumab, achieve remarkable clinical efficacy in patients with late stage cancers. However, only a small subset of patients benefit from this therapy.
Peng Yue, Taylor Harper, Silvia M. Bacot, Monica Chowdhury, Shiowjen Lee, Adovi Akue, Mark A. Kukuruga, Tao Wang, Gerald M. Feldman   +8 more
doaj   +1 more source

Informing selection of drugs for COVID-19 treatment through adverse events analysis

Scientific Reports, 2021
Coronavirus disease 2019 (COVID-19) is an ongoing pandemic and there is an urgent need for safe and effective drugs for COVID-19 treatment. Since developing a new drug is time consuming, many approved or investigational drugs have been repurposed for ...
Wenjing Guo, Bohu Pan, Sugunadevi Sakkiah, Zuowei Ji, Gokhan Yavas, Yanhui Lu, Takashi E. Komatsu, Madhu Lal-Nag, Weida Tong, Tucker A. Patterson, Huixiao Hong   +10 more
doaj   +1 more source

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

JAMA Network Open, 2020
Key Points Question Have the number and characteristics of pivotal efficacy trials supporting US Food and Drug Administration approval of new drugs and biologics changed during the past 3 decades?
A. Zhang, Jeremy Puthumana, Nicholas Downing, N. Shah, H. Krumholz, J. Ross   +5 more
semanticscholar   +1 more source

Evaluating the potential of gold, silver, and silica nanoparticles to saturate mononuclear phagocytic system tissues under repeat dosing conditions

Particle and Fibre Toxicology, 2017
Background As nanoparticles (NPs) become more prevalent in the pharmaceutical industry, questions have arisen from both industry and regulatory stakeholders about the long term effects of these materials. This study was designed to evaluate whether gold (
James L. Weaver, Grainne A. Tobin, Taylor Ingle, Simona Bancos, David Stevens, Rodney Rouse, Kristina E. Howard, David Goodwin, Alan Knapton, Xiaohong Li, Katherine Shea, Sharron Stewart, Lin Xu, Peter L. Goering, Qin Zhang, Paul C. Howard, Jessie Collins, Saeed Khan, Kidon Sung, Katherine M. Tyner   +19 more
doaj   +1 more source

Decoding kinase-adverse event associations for small molecule kinase inhibitors

Nature Communications, 2022
Small molecule kinase inhibitors (SMKIs) are being approved at a fast pace under expedited programs for anticancer treatment. Here, the authors employ a machine-learning model to examine the relationships between kinase targets and adverse events in the ...
Xiajing Gong, Meng Hu, Jinzhong Liu, Geoffrey Kim, James Xu, Amy McKee, Todd Palmby, R. Angelo de Claro, Liang Zhao   +8 more
doaj   +1 more source

Food and Drug Administration Regulation of Food Safety [PDF]

, 2011
Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually.
Gostin, Lawrence O., Stewart, Katie F.
core   +3 more sources

The role of PD-L1 expression as a predictive biomarker: an analysis of all US Food and Drug Administration (FDA) approvals of immune checkpoint inhibitors

Journal of Immunotherapy for Cancer, 2019
The development of immune checkpoint inhibitors has changed the treatment paradigm for advanced cancers across many tumor types. Despite encouraging and sometimes durable responses in a subset of patients, most patients do not respond.
A. Davis, V. Patel
semanticscholar   +1 more source

Health Disparities in Calorie Knowledge and Confidence Among the U.S. Adult Population

Journal of Primary Care & Community Health, 2021
Purpose Obesity prevalence has reached an all-time high in the US, affecting >40% of the population. This study’s objective was to evaluate associations between demographics and self-reported calorie knowledge and self-perceived confidence in calorie ...
Amy M. Lando, Martine S. Ferguson, Linda Verrill, Fanfan Wu, Olivia E. Jones-Dominic, Cecile Punzalan, Beverly J. Wolpert   +6 more
doaj   +1 more source

Atezolizumab potentiates Tcell-mediated cytotoxicity and coordinates with FAK to suppress cell invasion and motility in PD-L1+ triple negative breast cancer cells

OncoImmunology, 2019
Immune check point inhibitors targeting programmed cell death protein-1 (PD-1) and its ligand (PD-L1) have shown clinical success in treatment of human malignancies.
Nishant Mohan, Salman Hosain, Jun Zhao, Yi Shen, Xiao Luo, Jiangsong Jiang, Yukinori Endo, Wen Jin Wu   +7 more
doaj   +1 more source