Food and Drug Administration (FDA) Research This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Transcatheter aortic valve replacement in low-risk young population: A double edge sword?
World J Cardiol. 2024 Apr 26;16(4):177-180. doi: 10.4330/wjc.v16.i4.177.ABSTRACTSince the advent of transcatheter aortic valve replacement (TAVR) in 2002, it has now become the default interventional strategy for symptomatic patients presenting with severe aortic stenosis, particularly in intermediate to high-surgical risk patients. In 2019, the United States Food and Drug Administration approved TAVR in low-risk patients based on two randomized trials. However, these breakthrough trials excluded patients with certain unfavorable anatomies and odd profiles. While currently there is no randomized study of TAVR in young pati...
Source: World Journal of Cardiology - May 1, 2024 Category: Cardiology Authors: Sukhdeep Bhogal Akash Batta Source Type: research

Microsatellite Instability, Mismatch Repair, and Tumor Mutation Burden in Lung Cancer
Surg Pathol Clin. 2024 Jun;17(2):295-305. doi: 10.1016/j.path.2023.11.011. Epub 2023 Dec 20.ABSTRACTSince US Food and Drug Administration approval of programmed death ligand 1 (PD-L1) as the first companion diagnostic for immune checkpoint inhibitors (ICIs) in non-small cell lung cancer, many patients have experienced increased overall survival. To improve selection of ICI responders versus nonresponders, microsatellite instability/mismatch repair deficiency (MSI/MMR) and tumor mutation burden (TMB) came into play. Clinical data show PD-L1, MSI/MMR, and TMB are independent predictive immunotherapy biomarkers. Harmonization...
Source: Clinical Lung Cancer - May 1, 2024 Category: Cancer & Oncology Authors: Oana C Rosca Oana E Vele Source Type: research

Repurposing the multiple sclerosis drug Siponimod for osteoporosis treatment
Eur J Pharmacol. 2024 Apr 29:176630. doi: 10.1016/j.ejphar.2024.176630. Online ahead of print.ABSTRACTOsteoporosis is the most common bone disorder, in which an imbalance between osteoclastic bone resorption and osteoblastic bone formation disrupts bone homeostasis. Osteoporosis management using anti-osteoclastic agents is a promising strategy; however, this remains an unmet need. Sphingosine-1-phosphate (S1P) and its receptors (S1PRs) are essential for maintaining bone homeostasis. Here, we identified that Siponimod, a Food and Drug Administration-approved S1PR antagonist for the treatment of multiple sclerosis, shows pro...
Source: European Journal of Pharmacology - May 1, 2024 Category: Drugs & Pharmacology Authors: Sitao Hu Yangyang Hu Zenglin Tan Chengyu Zhou Cheng Zhang Sheng Yin Xiaojun Chen Kai Chen Lu Wang Lei Chen Source Type: research

Patterns of red blood cell utilization: Harnessing electronic health records data from the Information Standard for Blood and Transplant (ISBT) 128 system within the Biologics Effectiveness and Safety (BEST) initiative
This study shows that the ISBT 128 coding system in an EHR environment provides a feasible source for hemovigilance activities.PMID:38689458 | DOI:10.1111/trf.17852 (Source: Transfusion)
Source: Transfusion - May 1, 2024 Category: Hematology Authors: Joyce Obidi Gayathri Sridhar Gra ça M Dores Barbee Whitaker Carlos H Villa Emily Storch Kinnera Chada Lisa M Schilling Karthik Natarajan Paul Biondich Andrey Soares Matthew Spotnitz Thomas Falconer Saptarshi Purkayastha Nicole L Draper Hui-Lee Wong Matth Source Type: research

Current Status and Perspectives of Therapeutic Antibodies Targeting the Spike Protein S2 Subunit against SARS-CoV-2
Biol Pharm Bull. 2024;47(5):917-923. doi: 10.1248/bpb.b23-00639.ABSTRACTThe global coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has devastated public health and the global economy. New variants are continually emerging because of amino acid mutations within the SARS-CoV-2 spike protein. Existing neutralizing antibodies (nAbs) that target the receptor-binding domain (RBD) within the spike protein have been shown to have reduced neutralizing activity against these variants. In particular, the recently expanding omicron subvariants BQ 1.1 and XBB are res...
Source: Biological and Pharmaceutical Bulletin - May 1, 2024 Category: Drugs & Pharmacology Authors: Yuichiro Yamamoto Tetsuya Inoue Source Type: research

Orally dissolving buprenorphine for opioid use disorder linked to caries
J Am Dent Assoc. 2024 Apr 30:S0002-8177(24)00129-6. doi: 10.1016/j.adaj.2024.03.001. Online ahead of print.ABSTRACTBACKGROUND: Buprenorphine is under scrutiny because of the development of xerostomia and caries. The purpose of this article was to inform dental care professionals about the oral effects of buprenorphine and to increase knowledge and awareness of medication-assisted treatment in the management of opioid use disorder (OUD).CASE DESCRIPTION: In 2022, the US Food and Drug Administration issued a warning about xerostomia and caries associated with the use of transmucosal (sublingual and buccal formulations) bupre...
Source: Journal of the American Dental Association - May 1, 2024 Category: Dentistry Authors: Stuart L Segelnick Mea A Weinberg Source Type: research