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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Impact of Improved Sanitation Standard Operating Procedures on Microbial Populations at Three Tree Fruit Packing Facilities by M. Laura Rolon, Marysabel Mendez Acevedo, Priscilla Sinclair, Dumitru Macarisin, Luke F. LaBorde, Jasna Kovac

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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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Travoprost Intracameral Implant in Eyes with Glaucoma or Ocular Hypertension: Early Short-Term Real-World Outcomes by Teymoorian S, Kaur J

“…Savak Teymoorian, Jasmin Kaur Harvard Eye Associates, Laguna Hills, CA, USACorrespondence: Savak Teymoorian, Harvard Eye Associates, 23961 Calle de la Magdalena, Suite 300, Laguna Hills, California, 92653, USA, Tel +1 949-951-2020, Fax +1 949-356-1660, Email steymoorian@harvardeye.comPurpose: To assess real-world efficacy and safety of standalone travoprost intracameral implant (iDose TR) implantation by a US glaucoma surgeon in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).Methods: This non-randomized, retrospective, unmasked, consecutive case series included all cases of standalone iDose TR implantation from a single US glaucoma surgeon since the product’s approval by the US Food and Drug Administration (FDA) in December 2023. Patients were pseudophakic, had OAG or OHT, and had undergone prior SLT and/or bimatoprost intracameral implant injection (Durysta). …”
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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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Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treat... by B Tucker Woodson, Maria V Suurna, M Boyd Gillespie, Tod C Huntley, Melyssa Hancock, Angela Santos, Jeyakumar Subbaroyan, Fatima Makori, Grégoire Fesneau, Clemens Heiser, David T Kent

“…Secondary effectiveness endpoints include mean changes in quality-of-life assessments (daytime sleepiness and its effect on activities of daily living, OSA-specific quality of life, daytime sleepiness), levels of intermittent hypoxia, change in hypoxaemic burden and OSA severity.Ethics and dissemination The Food and Drug Administration, Advarra Institutional Review Board (IRB), University of Tennessee HSC IRB, University of Pennsylvania IRB, Weill Cornell Medicine IRB, Medical College of Wisconsin/Froedert Hospital, Human Research Protections Programme Vanderbilt University, St. …”
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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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Inhibition of anti-tumour reactivity of immune cells in the salivary gland cancer: A proteomic approach by Rajdeep Chakraborty, Charbel Darido, Aidan Tay, Thiri Zaw, Shoba Ranganathan, Fei Liu, Giuseppe Palmisano

“…Pembrolizumab, an immune checkpoint inhibitor, has been approved by the Food and Drug Administration for the treatment of squamous cell carcinomas of the head and neck region. …”
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Disproportionality analysis of upadacitinib-related adverse events in inflammatory bowel disease using the FDA adverse event reporting system by Shiyi Wang, Xiaojian Wang, Jing Ding, Xudong Zhang, Hongmei Zhu, Yihong Fan, Changbo Sun

“…This study evaluates upadacitinib-related adverse events (AEs) utilizing data from the US Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsWe employed disproportionality analyses, including the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) algorithms to identify signals of upadacitinib-associated AEs for treating inflammatory bowel disease (IBD).ResultsFrom a total of 7,037,004 adverse event reports sourced from the FAERS database, 37,822 identified upadacitinib as the primary suspect drug in adverse drug events (ADEs), including 1,917 reports specifically related to the treatment of inflammatory bowel disease (IBD). …”
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A novel model-based meta-analysis to indirectly estimate the comparative efficacy of two medications: an example using DPP-4 inhibitors, sitagliptin and linagliptin, in treatment o... by Yan Gong, James Rogers, Christian Friedrich, Sanjay Patel, Alexander Staab, Jorge Luiz Gross, Daniel Polhamus, William Gillespie, Brigitta Ursula Monz, Silke Retlich

“…Comparison of two oral dipeptidyl peptidase (DPP)-4 inhibitors, sitagliptin and linagliptin, for type 2 diabetes mellitus (T2DM) treatment was used as an example.Design Systematic review with MBMA.Data sources MEDLINE, EMBASE, http://www.ClinicalTrials.gov, Cochrane review of DPP-4 inhibitors for T2DM, sitagliptin trials on Food and Drug Administration website to December 2011 and linagliptin data from the manufacturer.Eligibility criteria for selecting studies Double-blind, randomised controlled clinical trials, ≥12 weeks’ duration, that analysed sitagliptin or linagliptin efficacies as changes in glycated haemoglobin (HbA1c) levels, in adults with T2DM and HbA1c &gt;7%, irrespective of background medication.Model development and application A Bayesian model was fitted (Markov Chain Monte Carlo method). …”
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Dihydrotanshinone I enhanced BRAF mutant melanoma treatment efficacy by inhibiting the STAT3/SOX2 signaling pathway by Xing Luo, Yi Duan, Jinwei He, CongGai Huang, Jun Liu, Yifan Liu, Mengdei Xu, Qiong Dai, Zhihui Yang

“…BackgroundThe Food and Drug Administration has approved the Serine/threonine-protein kinase B-raf (BRAF) inhibitor and Mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor combo as the first-line treatment for individuals with metastatic melanoma, although the majority of these patients exhibit primary or secondary drug resistance in the clinic. …”
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Concerns Over Vuse e-Cigarette Digital Marketing and Implications for Public Health Regulation: Content Analysis by Eileen Han, Lauren K Lempert, Francesca Vescia, Bonnie Halpern-Felsher

“…In October 2021, Vuse Solo became the first e-cigarette brand to receive marketing granted orders (MGOs) from the US Food and Drug Administration (FDA), authorizing its marketing and their tobacco-flavored pods. …”
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