Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol by Mekonnen Teferi, Claire Kamaliddin, Hiwot Tilahun, Rediet Fikru Gebresenbet, Zelalem Mekonnen Bekele, Banchamlak Tegegne, Delenasaw Yewhalaw, Abebe Genetu Bayih, Dylan R Pillai, Filmona Mekuria, Getaneh Alemu, Beka Raya, Omar Abdullah, Taye Teka, James Cheaveau, Ruth Legese, Hiwot Asmerom, Ermias Hundito, Ebrahim Nursefa, Samuel Ayele

“…The primary outcome of the study is to measure birth weight.Ethics and dissemination The study was approved by the following ethical research boards: Armauer Hansen Research Institute/ALERT Ethics Review Committee (FORM AF-10-015.1, Protocol number PO/05/20), the Ethiopia Ministry of Science and Higher Education National Research Ethics Review Committee (approval SRA/11.7/7115/20), the Ethiopia Food and Drug Administration (approval 02/25/33/I), UCalgary Conjoint Health Research Ethics Board (REB21-0234). …”
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Drug-induced autoimmune-like hepatitis: A disproportionality analysis based on the FAERS database. by Wangyu Ye, Yuan Ding, Meng Li, Zhihua Tian, Shaoli Wang, Zhen Liu

“…This study aimed to systematically identify drugs linked to DI-ALH by analyzing adverse event reports from the U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) database.…”
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Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database by Chuang Yang, Bangjian Deng, Qiang Wen, Pei Guo, Xiang Liu, Chen Wang

“…ObjectiveThis study aimed to evaluate the safety profile of sevoflurane in pediatric populations using real-world data.MethodsData were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. …”
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The Effect of Lithium on Inflammation-Associated Genes in Lipopolysaccharide-Activated Raw 264.7 Macrophages by Raymond T. Makola, Vusi G. Mbazima, Matlou P. Mokgotho, Vincent S. Gallicchio, Thabe M. Matsebatlela

“…Lithium remains the preferred Food and Drug Administration- (FDA-) approved psychiatric drug for treatment of bipolar disorders since its medical establishment more than half a century ago. …”
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Adverse events in different administration routes of amiodarone: a pharmacovigilance study based on the FDA adverse event reporting system by Jingrong Yang, Mengfan You, Jingxin Wang, Rongfei Sun, Lili Han, Xiaonan Liu, Kaibin Niu, Kaidi Xing, Juanping Sun, Wenge Su, Yifei Wang

“…This study aims to address this gap by utilizing the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) to investigate the spectrum and timing of AEs related to amiodarone administration through disproportionality analysis and stratification methods.MethodsData from the FAERS database were analyzed using disproportionality analysis and reporting odds ratio (ROR) methods for comparative analysis, and the Weibull distribution for time-to-adverse-event analysis. …”
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Assessing patient risk, benefit and outcomes in drug development: an observational study of regorafenib clinical trials by Matt Vassar, Vinay Prasad, Ryan McIntire, Alyson Haslam, Brody Dennis, Chance Bratten, Griffin K Hughes, Andriana M Peña, Chase Ladd, Brooke Gardner, William Nowlin, Reagan Livingston, Jordan Tuia

“…Cumulative risk to patients increased over time while ORR stayed consistently low.Conclusions Our findings suggest that since regorafenib’s original Food and Drug Administration (FDA) approval, the risk profile for its original indication increased. …”
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Evaluating the Effectiveness of mRNA-1273.815 Against COVID-19 Hospitalization Among Adults Aged ≥ 18 Years in the United States by Amanda Wilson, Neloufar Rahai, Ekkehard Beck, Elisha Beebe, Brian Conroy, Daina Esposito, Priya Govil, Hagit Kopel, Tianyi Lu, James Mansi, Morgan A. Marks, Katherine E. Mues, Rohan Shah, Michelle Skornicki, Tianyu Sun, Astra Toyip, Mitra Yousefi, David Martin, Andre B. Araujo

“…Abstract Introduction In September 2023 the Food and Drug Administration (FDA) approved an updated mRNA COVID-19 vaccine targeting the XBB.1.5 sublineage. …”
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Adverse drug events (ADEs) risk signal mining related to eculizumab based on the FARES database by Xi-Feng Wang, Lu-Ri Bao, Ta-La Hu, Rui-Feng Xu, Wu-Niri Gao, Jing-Yuan Wang, Jian-Rong Zhao, Zhen-Li Fu, Shu-Fang Wang, Yan Meng

“…The current study was conducted to assess real-world adverse events (AEs) associated with eculizumab through data mining of the FDA Adverse Event Reporting System (FAERS).MethodsDisproportionality analyses, including Reporting Ratio Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms were used to quantify the signals of eculizumab-associated AEs.ResultsA total of 46,316 eculizumab-related ADEs reports were identified by analyzing 19,418,776 reports in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. …”
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Art of TIL immunotherapy: SITC’s perspective on demystifying a complex treatment by Robert Brown, Marco Donia, Simon Turcotte, George Coukos, John Mullinax, Brian Gastman, James C Yang, Michael T Lotze, John B A G Haanen, Inge Marie Svane, Stephanie L Goff, Vernon K Sondak, Maartje W Rohaan, Michal Besser, Benjamin Creelan

“…The infusion of autologous tumor-infiltrating T lymphocytes (TIL) is capable of mediating durable tumor regression and is now Food and Drug Administration-approved for patients with disease refractory to immune checkpoint inhibitors. …”
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Determination of Methomyl Residues in Bohe by Ultrahigh-Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS) by Yao Zheng, Addotey Tracy Naa Adoley, Benkhelifa Fateh, Wei Wu, Gengdong Hu, Liping Qiu, Jiazhang Chen

“…In our case, we suggest that a safety interval in the range of 15–20 days should be allowed after the detection of methomyl in water, and the concentration of methomyl was lower than the acceptable daily intake (ADI) of the China Food and Drug Administration (CFDA) (20 μg/kg).…”
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Janus kinase inhibitor treatment for inflammatory diseases: excess or no excess risk of venous thromboembolism? by Yachar Dawudi, Samuel Benarroch, Hélène Helfer, David M. Smadja, Isabelle Mahé

“…Nevertheless, these data have led regulatory organizations such as the Food and Drug Administration and the European Medicines Agency to issue precautionary measures regarding the use of JAKis in inflammatory diseases. …”
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Survival of Salmonella on Biodegradable Mulch, Landscape Fabric, and Plastic Mulch by Alyssa A. Rosenbaum, Claire M. Murphy, Annette L. Wszelaki, Alexis M. Hamilton, Steven L. Rideout, Laura K. Strawn

“…If counts dropped below the detection limit (<0.12 log CFU/cm2), enrichments were performed following the Food and Drug Administration’s Bacteriological Analytical Manual Salmonella protocol. …”
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Caution when using network partners for target identification in drug discovery by Dandan Tan, Yiheng Chen, Yann Ilboudo, Kevin Y.H. Liang, Guillaume Butler-Laporte, J. Brent Richards

“…Two recent papers from Open Targets claimed that around half of US Food and Drug Administration-approved drugs had targets with direct human genetic evidence. …”
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Clofarabine induces tumor cell apoptosis, GSDME-related pyroptosis, and CD8+ T-cell antitumor activity via the non-canonical P53/STING pathway by Jing Chen, Jie Wu, Xiang Chen, Qian Tao, Nian Liu, Cong Peng, Can Lu, Qiuqiu Li

“…Background Clofarabine (Clo) is a Food and Drug Administration (FDA)-approved drug for the treatment of acute lymphoblastic leukemia; however, its effects on solid tumors remain largely unknown.Methods In vitro and in vivo experiments have demonstrated the cytotoxic effects of Clo on melanoma and lung cancer. …”
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Compact Quantum Cascade Laser-Based Noninvasive Glucose Sensor Upgraded with Direct Comb Data-Mining by Liying Song, Zhiqiang Han, Hengyong Nie, Woon-Ming Lau

“…Mid-infrared spectral analysis has long been recognized as the most accurate noninvasive blood glucose measurement method, yet no practical compact mid-infrared blood glucose sensor has ever passed the accuracy benchmark set by the USA Food and Drug Administration (FDA): to substitute for the finger-pricking glucometers in the market, a new sensor must first show that 95% of their glucose measurements have errors below 15% of these glucometers. …”
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A truncated pre-F protein mRNA vaccine elicits an enhanced immune response and protection against respiratory syncytial virus by Min Lin, Yifan Yin, Xiaomeng Zhao, Chen Wang, Xueqing Zhu, Letao Zhan, Li Chen, Siling Wang, Xue Lin, Jun Zhang, Ningshao Xia, Zizheng Zheng

“…Abstract The Food and Drug Administration (FDA) has approved vaccines designed by GSK, Pfizer and Moderna to protect high-risk populations against respiratory syncytial virus (RSV). …”
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Fournier Gangrene Associated with Sodium-Glucose Cotransporter-2 Inhibitors: A Pharmacovigilance Study with Data from the U.S. FDA Adverse Event Reporting System by Yang Hu, Ziyu Bai, Yan Tang, Rongji Liu, Bin Zhao, Jian Gong, Dan Mei

“…Background. The U.S. Food and Drug Administration (FDA) released a safety warning of Fournier gangrene (FG), a rare but serious adverse effect of sodium-glucose cotransporter-2 (SGLT2) inhibitors in August 2018. …”
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Hepatitis associated with immune checkpoint inhibitors-based combinations of other therapies: A real-world pharmacovigilance analysis based on the FDA adverse event reporting syste... by Zhaohui Li, Zixiang Zhou, Nan Zhang, Binhe Tian, Xiangqi Chen, Haitao Zhao, Hanping Wang

“…We conducted this pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS). …”
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Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gynecologic cancer by Anne Mills, Leisha A Emens, Mary L Disis, Kunle Odunsi, John B Liao, Tyler Curiel, Margaret Gatti-Mays, Amir Jazaeri, Emese Zsiros, Marcus O Butler, Jyoti Bajpai, Katherine C Kurnit, Haider Mahdi, Laura Doherty, Claire F Friedman, Melissa A Geller, Sarah F Adams, Shelley A Dodt, Veena S John

“…Recently, immune checkpoint inhibitors (ICIs) have been approved by the US Food and Drug Administration for the treatment of cervical cancer and endometrial cancer, offering durable responses for some patients. …”
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Tobacco Use, Risk Perceptions, and Characteristics of Adults Who Used a Heated Tobacco Product (IQOS) in the United States: Cross-Sectional Survey Study by Hui G Cheng, Brendan Noggle, Andrea R Vansickel, Edward G Largo, Pierpaolo Magnani

“… BackgroundThe Tobacco Heating System (THS; commercialized as IQOS) is a smoke-free heated tobacco product introduced in the United States in 2019 and authorized by the US Food and Drug Administration as a modified risk tobacco product (MRTP) in 2020. …”
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