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.

Gastrointestinal Acute Radiation Syndrome: Mechanisms, Models, Markers, and Medical Countermeasures
This report provides an overview of information that was presented during the conference, and important discussions surrounding a broad range of topics that are critical for the research, development, licensure, and use of MCMs for GI-ARS.PMID:38616048 | DOI:10.1667/RADE-23-00196.1 (Source: Radiation Research)
Source: Radiation Research - April 14, 2024 Category: Physics Authors: Thomas A Winters Libero Marzella Olivia Molinar-Inglis Paul W Price Nyun Calvin Han Jonathan E Cohen Sue-Jane Wang Anthony F Fotenos Julie M Sullivan John Esker Paula J Lapinskas Andrea L DiCarlo Source Type: research

Incidence of Newly Recognized Atrial Fibrillation in Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Mavacamten
Mavacamten is a cardiac myosin inhibitor that has been shown to reduce left ventricular outflow tract obstruction in obstructive hypertrophic cardiomyopathy (oHCM).1 In late-stage clinical trials, atrial fibrillation (AF) represented an adverse event in 2-4 % of the patients randomized to mavacamten.1,2 However, the effect of mavacamten on the frequency and management of new/recurrent AF episodes in oHCM receiving mavacamten following its Food and Drug Administration (FDA) approval remains only partially explored. (Source: Heart Rhythm)
Source: Heart Rhythm - April 13, 2024 Category: Cardiology Authors: Matteo Castrichini, Said Alsidawi, Jeffrey B. Geske, Darrell B. Newman, Adelaide M. Arruda-Olson, J. Martijn Bos, Steve R. Ommen, Konstantinos C. Siontis, Michael J. Ackerman, John R. Giudicessi Source Type: research

Carbon 14 and Carbon 13 Syntheses of Velagliflozin
The oral solution of velagliflozin, SENVELGO, is the first liquid once daily, orally administered prescription medication to treat cats with diabetes. The detailed synthesis of carbon 14 – and carbon 13–labeled velagliflozin is described. ABSTRACTVelagliflozin is the active ingredient of the first oral liquid medication approved by the Food and Drug Administration for the treatment of diabetes in cats. This compound belongs to the known class of sodium-glucose cotransporter 2 inhibitors approved to treat diabetes in human. Here, we report the detailed synthesis of velagliflozin labeled with carbon 14 and carbon 13. (So...
Source: Journal of Labelled Compounds and Radiopharmaceuticals - April 12, 2024 Category: Biochemistry Authors: Bachir Latli, Matt J. Hrapchak, Maxim Chevliakov, Chutian Shu Tags: RESEARCH ARTICLE Source Type: research

FDA Okays First Drug for Scarring From Fatty Liver Disease
The US Food and Drug Administration (FDA) recently approved resmetirom, marketed as Rezdiffra, for adults with nonalcoholic steatohepatitis (NASH) without cirrhosis. NASH is a progressive fatty liver disease that affects up to 8 million people in the US and can cause liver inflammation and scarring, known as fibrosis. Resmetirom, an oral drug that reduces the accumulation of liver fat, can be used along with diet and exercise, which are the standard care for patients with NASH. (Source: JAMA - Journal of the American Medical Association)
Source: JAMA - Journal of the American Medical Association - April 12, 2024 Category: General Medicine Source Type: research

Method development and validation for the estimation of gedatolisib in mouse plasma by tandem mass spectrometry and its application to pharmacokinetics studies
Biomed Chromatogr. 2024 Apr 10:e5878. doi: 10.1002/bmc.5878. Online ahead of print.ABSTRACTA simple and a sensitive liquid chromatography-tandem mass spectrometry method was developed and validated for the quantification of gedatolisib in mouse plasma. The extraction technique involved a simple precipitation method to extract gedatolisib and idelalisib (internal standard) from mouse plasma. A clean chromatographic separation of gedatolisib and the internal standard was achieved on an Atlantis dC18 column using an isocratic mobile phase (10 mm ammonium formate and acetonitrile; 30:70% v/v, both supplemented with 0.1% formic...
Source: Biomedical Chromatography : BMC - April 11, 2024 Category: Biomedical Science Authors: Vinod A B Arunava Das Source Type: research

Acesulfame potassium upregulates PD-L1 in HCC cells by attenuating autophagic degradation
Biochem Biophys Res Commun. 2024 Apr 9;711:149921. doi: 10.1016/j.bbrc.2024.149921. Online ahead of print.ABSTRACTArtificial sweeteners, which contain no or few calories, have been widely used in various foods and beverages, and are regarded as safe alternatives to sugar by the Food and Drug Administration. While several studies suggest that artificial sweeteners are not related to cancer development, some research has reported their potential association with the risk of cancers, including hepatocellular carcinoma (HCC). Here, we investigated whether acesulfame potassium (Ace K), a commonly used artificial sweetener, indu...
Source: Biochemical and Biophysical Research communications - April 11, 2024 Category: Biochemistry Authors: Dong-Ho Kim Eun-Jun Kwon Keun-Gyu Park Jonghwa Jin Jun-Kyu Byun Source Type: research

Acesulfame potassium upregulates PD-L1 in HCC cells by attenuating autophagic degradation
Biochem Biophys Res Commun. 2024 Apr 9;711:149921. doi: 10.1016/j.bbrc.2024.149921. Online ahead of print.ABSTRACTArtificial sweeteners, which contain no or few calories, have been widely used in various foods and beverages, and are regarded as safe alternatives to sugar by the Food and Drug Administration. While several studies suggest that artificial sweeteners are not related to cancer development, some research has reported their potential association with the risk of cancers, including hepatocellular carcinoma (HCC). Here, we investigated whether acesulfame potassium (Ace K), a commonly used artificial sweetener, indu...
Source: Cell Research - April 11, 2024 Category: Cytology Authors: Dong-Ho Kim Eun-Jun Kwon Keun-Gyu Park Jonghwa Jin Jun-Kyu Byun Source Type: research

Infections Associated with Medtronic Duet External Ventricular Drains - Rhode Island Hospital, Providence, Rhode Island, January 2023-January 2024
MMWR Morb Mortal Wkly Rep. 2024 Apr 11;73(14):312-316. doi: 10.15585/mmwr.mm7314a4.ABSTRACTExternal ventricular drains (EVDs) are medical devices that are inserted into the ventricles of the brain to drain excess fluid, manage intracranial hypertension, monitor intracranial pressure, and administer medications. Unintentional disconnections and breaks or fractures (breaks) of EVDs or associated drainage system components can result in cerebrospinal fluid (CSF) leakage and increased risk for EVD-associated infections. After replacement of Integra Life Sciences EVD systems with Medtronic Duet EVD systems at Rhode Island Hospi...
Source: MMWR Morb Mortal Wkl... - April 11, 2024 Category: Epidemiology Authors: Kevin M Gibas Dianne Auld Stephanie Parente Jean Horoho Leonard A Mermel Source Type: research