Sentiments of Individuals with Interstitial Cystitis/Bladder Pain Syndrome Toward Pentosan Polysulfate Sodium: Infodemiology Study by Yulin Hswen, Qiuyuan Qin, Pressley Smith, Alison Swierczynski, Stuart Bauer, Erika Ladson, Amanda Leigh Garrett, Catherine A Brownstein

“…The only US Food and Drug Administration–approved medication to treat IC/BPS is pentosan polysulfate sodium (PPS). …”
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Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types by Jeffrey S Ross, Richard S P Huang, Jake G Maule, Lani K Clinton, Ryon P Graf, Jinpeng Xiao, Geoffrey R Oxnard

“…Background Multiple PD-L1 immunohistochemistry (IHC) assays, including DAKO 22C3, DAKO 28-8, and Ventana SP142 PD-L1 IHC assays, have been approved by the Food and Drug Administration as a companion diagnostic (CDx) for various antiprogrammed death-1 and antiprogrammed death ligand 1 (PD-L1) based cancer immunotherapies. …”
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Exploring the ability of plasma pTau217, pTau181 and beta-amyloid in mirroring cerebrospinal fluid biomarker profile of Mild Cognitive Impairment by the fully automated Lumipulse®... by Marcella Catania, Claudia Battipaglia, Alberto Perego, Erika Salvi, Emanuela Maderna, Federico Angelo Cazzaniga, Paolo M. Rossini, Camillo Marra, Nicola Vanacore, Alberto Redolfi, Daniela Perani, Patrizia Spadin, Maria Cotelli, Stefano Cappa, Naike Caraglia, Pietro Tiraboschi, Fabrizio Tagliavini, Giuseppe Di Fede

“…Abstract Background The approval of new disease-modifying therapies by the U.S. Food and Drug Administration and the European Medicine Agency makes it necessary to optimize non-invasive and cost-effective tools for the identification of subjects at-risk of developing Alzheimer’s Disease (AD). …”
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Traditional herbal medicine legislative and regulatory framework: a cross-sectional quantitative study and archival review perspectives by Sileshi Dubale, Rashed Edris Usure, Yesuneh Tefera Mekasha, Gemmechu Hasen, Firdos Hafiz, Dereje Kebebe, Sultan Suleman

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Clozapine for Treatment-Resistant Disruptive Behaviors in Youths With Autism Spectrum Disorder Aged 10-17 Years: Protocol for an Open-Label Trial by André Luiz Schuh Teixeira da Rosa, Marina Ribeiro Barreto da Costa, Gabriela Bezerra Sorato, Felipe de Moura Manjabosco, Érica Bonganhi de Bem, Lucas Dellazari, Arthur Bezerra Falcão, Lucas de Oliveira Cia, Olivia Sorato Bezerra, Rogério Boff Borges, Luis Augusto Rohde, Ana Soledade Graeff-Martins

“…The atypical antipsychotics risperidone and aripiprazole, currently the only Food and Drug Administration–approved treatments for severe DB in patients with ASD, often encounter therapeutic failure or intolerance. …”
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Comparison of GLP-1RAs vs Other Pharmacotherapy for Obesity by Andrew Overholser, Eric Czech, Linda Speer, Joel Wilson, Alex Overholser

“…The current United States Food and Drug Administration (FDA) approved pharmaceutical therapy choices for long-term use include a combination of phentermine-topiramate, combination bupropion-naltrexone, orlistat, glucagon-like peptide-1 receptor agonists (GLP-1RAs), and dual action GLP-1RAs and gastric inhibitory peptide agonists (GIP). …”
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N-Butyl-2-Cyanoacrylate Adhesive Versus Absorbable Tacks in Laparoscopic Groin Hernia Repair: A Multicenter Randomized Clinical Trial by Clayton C. Petro, MD, Benjamin K. Poulose, MD, Michael J. Rosen, MD, Alfredo M. Carbonell, II, DO, Adel G. El-Ghazzawy, MD, Jeremy A. Warren, MD, Emanuele Lo Menzo, MD, Ajita S. Prabhu, MD, David M. Krpata, MD, Samuel Szomstein, MD, Vimal Narula, MD, Crystal F. Totten, MD, Kelly R. Haisley, MD, Andrew C. Bernard, MD, Henrik O. Berdel, MD, Jessica K. Reynolds, MD, Zachary D. Warriner, MD, John S. Roth, MD

“…Chronic pain after laparoscopic groin hernia repair has been associated with penetrating fixation, but there had been no US Food and Drug Administration–approved devices for nonpenetrating fixation in this context. …”
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Development and characterization of orthotopic patient-derived xenograft models of peritoneal metastatic mucinous appendiceal adenocarcinoma by I. Ito, V.K. Pattalachinti, A.M.G. Yousef, S. Chowdhury, M.M. Fanaeian, E. Haque, B.B. Gunes, M. Yousef, E.R. Salle, M.A. Zeineddine, S. Ji, R. Li, W. Wang, B.A. Helmink, M.W. Taggart, M.G. White, K.F. Fournier, N.W. Fowlkes, J.P. Shen

“…The lack of preclinical models of AA has hindered drug development and is a major factor in why AA remains without a single Food and Drug Administration-approved systemic treatment. Materials and methods: Tumors from 16 patients with appendiceal neoplasms (15 AAs and 1 high-grade appendiceal neoplasm) were implanted into the flank and the peritoneal cavity of immunodeficient mice leading to the successful establishment of three AAPDX models. …”
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Comprehensive Cellular Senescence Evaluation to Aid Targeted Therapies by Xiaolan Zhou, Xiaofeng Zhu, Weixu Wang, Jing Wang, Haimei Wen, Yuqi Zhao, Jiayu Zhang, Qiushi Xu, Zhaozhao Zhao, Ting Ni

“…Drug resistance to a single agent is common in cancer-targeted therapies, and rational drug combinations are a promising approach to overcome this challenge. Many Food and Drug Administration-approved drugs can induce cellular senescence, which possesses unique vulnerabilities and molecular signatures. …”
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Potentially commercializable nerve guidance conduits for peripheral nerve injury: Past, present, and future by Chundi Liu, Mouyuan Sun, Lining Lin, Yaxian Luo, Lianjie Peng, Jingyu Zhang, Tao Qiu, Zhichao Liu, Jun Yin, Mengfei Yu

“…To enhance comprehension of clinical situations, this article provides a comprehensive analysis of the clinical efficacy of nerve conduits approved by the United States Food and Drug Administration. It proposes that the initial six months post-transplantation is a critical window period for evaluating their efficacy. …”
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Examining the effect of direct-from-blood bacterial testing on antibiotic administration and clinical outcomes: a protocol and statistical analysis plan for a pragmatic randomised... by Li Wang, Wesley H Self, Todd W Rice, Matthew W Semler, Karen F Miller, Cheryl L Gatto, Andrea Fletcher, Romney M Humphries, Joanna L Stollings, Adrienne Baughman, Jakea Johnson, Edward T Qian, Mary Lynn Dear, David C Gaston, Ariel A Lewis, George E Nelson, Benjamin J Ereshefsky, Matthew A Christensen, Ritu Banerjee, Dan Albert, Alison Benton, Laura Bobbitt, Carleigh Burns, Timothy Duff, David C. Gaston, MLS Sharon Glover, Allyson Hobbie, Austin Ing, Gabriel Kemp, Sheryl Mangrum, Geoff Mavrak, Kelly Moser, David Mulherin, Shannon Pugh, Matthew Rodgers, Chrissie Schaeffer, Adam Turner, Sabrina Shipman, Halden Z VanCleave, Hamilton Wen Li Wang, LaKeysha Wiggins

“…Eligible patients are randomised 1:1 to receive Food and Drug Administration-approved direct-from-blood bacterial testing in addition to blood cultures or blood cultures alone. …”
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Toxoplasma gondii in dromedary camels (Camelus dromedarius) in Egypt: a comparative seroepidemiological study in Upper and Lower Egypt by Ehab Kotb Elmahallawy, Ehab Kotb Elmahallawy, Nady Khairy Elbarbary, David Cano-Terriza, David Cano-Terriza, Tomás Fajardo, Nada Oudah Albalawi, Débora Jiménez-Martín, Marwa M. I. Ghallab, Ahmed Gareh, Refaat Ras, Refaat Ras, Isabelle Villena, Sabry A. S. Sadek, Hajar AlQadeeb, Hind Alzaylaee, Sonia Almería, Ignacio García-Bocanegra, Ignacio García-Bocanegra

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Tumor mutational burden and survival on immune checkpoint inhibition in >8000 patients across 24 cancer types by Vivek Subbiah, Samuel J Klempner, Neeraj Agarwal, David P Carbone, Amit Mahipal, Shilpa Gupta, David Fabrizio, Jeffrey S Ross, Gerald Li, David R Gandara, Miles C Andrews, Jonathan W Riess, Ramez N Eskander, Ryon P Graf, Geoffrey R Oxnard, Sarah Sammons, Jeremy Snider, Lilia Bouzit, Cheryl Cho-Phan, Megan Price, Julia C F Quintanilha, Richard Sheng Poe Huang

“…The KEYNOTE 158 trial supported United States Food and Drug Administration (FDA) approval of the Foundation Medicine test (FoundationOneCDx) at TMB≥10 mut/Mb as a companion diagnostic (CDx) for single-agent pembrolizumab in second+line. …”
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Immune and genomic biomarkers of immunotherapy response in cancer of unknown primary by Madhu Singh, Linda Mileshkin, Penelope Schofield, Bo Gao, Gary Richardson, Andrew Pattison, Rodney J Hicks, Niko Thio, Mark Warren, Colin Wood, Stephen B Fox, Anna DeFazio, Andrew Fellowes, Christopher Steer, David Bowtell, Nicholas Wilcken, Tharani Sivakumaran, Atara Posner, Dariush Etemadmoghadam, Krista Fisher, Samantha Webb, Christos S Karapetis, Ian M Collins, Narayan Karanth, Owen W J Prall, Richard William Tothill

“…ICI responsive cancer types were assigned based on Food and Drug Administration-approved indications, and either detection of a latent primary tumor or the TOO was suspected based on genomics informed pathology review. …”
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Comments on: “Early High-Titer Convalescent Plasma Therapy in Patients with Moderate and Severe COVID-19” [Transfusion and Apheresis Science 61 (2022) 103321] by Seyed Reza Hosseiniara

“…It is plausible that patients receiving therapy later experienced longer hospital stays, which may have contributed to poorer outcomes, as previous research has shown a correlation between extended hospital stays and increased mortality risk in COVID-19 patients.9 Therefore, the authors' assertion regarding the efficacy of high-titer convalescent plasma therapy as a therapeutic option for patients with moderate COVID-19 during the early stages of the disease should be interpreted with caution.Additionally, the authors emphasize that "The use of COVID-19 convalescent plasma (CCP) has been approved by the Food and Drug Administration (FDA)." However, it is important to highlight that clinical trials adhering to the FDA's convalescent plasma treatment protocol have yielded concerning results. …”
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Safety and effects of anti-obesity medications on weight loss, cardiometabolic, and psychological outcomes in people living with overweight or obesity: a systematic review and meta... by Leiling Liu, Zhiqi Li, Wenrui Ye, Pu Peng, Yurong Wang, Luqing Wan, Jiangnan Li, Mei Zhang, Yihua Wang, Runqi Liu, Danyan Xu, Jingjing Zhang

“…Randomised controlled trials evaluating weight-loss pharmacotherapies approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) for treating overweight or obesity were included. …”
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The American Society of Pain and Neuroscience (ASPN) Guidelines and Consensus on the Definition, Current Evidence, Clinical Use and Future Applications for Physiologic Closed-Loop... by Pope JE, Deer TR, Sayed D, Antony AB, Bhandal HS, Calodney AK, Chakravarthy K, Costandi S, Diep J, Durbhakula S, Fishman MA, Gilligan C, Goree JH, Guirguis M, Hagedorn JM, Hunter CW, Kallewaard JW, Kapural L, Lam CM, Li S, Mayrsohn B, Nijhuis H, Nikolic S, Petersen EA, Poree LR, Puri SK, Reece DE, Rosen SM, Russo MA, Shah JM, Staats PS, Verrills P, Vu CM, Levy RM, Mekhail N

“…Recently, the Food and Drug Administration (FDA) released a guidance on physiologic closed loop controlled (PCLC) devices, highlighting the potential for these therapies to deliver accurate, consistent, real-time therapy, enhancing medical care and reducing variability. …”
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Cervical cancer screening: Impact of collection technique on human papillomavirus detection and genotyping by Alisa P. Young, Mutiya Olorunfemi, Leigh Morrison, Scott A. Kelley, Anna Laurie, Anna McEvoy, Jill Schneiderhan, Julie Prussack, Marie Claire O'Dwyer, Pamela Rockwell, Philip Zazove, Jonathan Gabison, Jane Chargot, Kristina Gallagher, Ananda Sen, Dongru Chen, Elizabeth A. Haro, Emma A. Butcher, Martha L. Alves, Christelle El Khoury, Melinda L. Dendrinos, Nicole Brashear, Roger Smith, Richard W. Lieberman, Natalie Saunders, Elizabeth Campbell, Heather M. Walline, Diane M. Harper

“…Background: The Food and Drug Administration (FDA) in the US approved primary human papillomavirus (HPV) testing for speculum-based cervical cancer screening ten years ago and, in May 2024, approved the self-collection technique. …”
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Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials by Gianna Strand

“…[xl]  Pierson et al., supra. [xli]  Food and Drug Administration, supra. [xlii]  Hurst, supra. …”
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Approved antibacterial drugs in the last 10 years: from the bench to the clinic by Miguel García-Castro, Francisco Sarabia, Amelia Díaz-Morilla, Juan Manuel López-Romero

“…This article covers the most recent antibacterial molecules approved by the Food and Drugs Administration (FDA) and European Medicines Agency (EMA) from 2012 to 2022 and intends to focus on synthetic derivatives to give a pedagogical view, with the goal of highlighting the importance of organic synthesis to obtain greater efficacy. …”
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