Results 21 to 30 of about 551,808 (299)

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
MORETTI, Ugo, De Ponti F., Sturkenboom, M, Sturkenboom, M.C.J.M. (Miriam), De Ponti, F, Behr, E.R. (Elijah), Koci A, Spina, E, Sturkenboom M, Ariola Koci, Poluzzi E, Spina E, Raschi, E. (Emanuel), Ponti, F. (Fabrizio) de, Ugo Moretti, Spina, E. (Edoardo), Poluzzi, E, POLUZZI, ELISABETTA, Koci, A. (Ariola), Behr ER, Koci, A, Elijah R. Behr, Elisabetta Poluzzi, Poluzzi, E. (Elisabetta), Sturkenboom, MCJM, Moretti, U. (Ugo), Fabrizio De Ponti, KOCI, ARIOLA, Moretti, U, Emanuel Raschi, Raschi, E, Miriam Sturkenboom, DE PONTI, FABRIZIO, Moretti U, RASCHI, EMANUEL, Behr, ER, Raschi E, Edoardo Spina   +37 more
core   +1 more source

A review of new drugs approved by the food and drug administration in 2022

Journal of Family Medicine and Primary Care, 2023
Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects.
Arjun Swaminathan, AE Vijayakumar, P Nikhithaa   +2 more
doaj   +1 more source

Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research

Frontiers in Medicine, 2017
Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration’s ...
Marc Kusinitz, Emily Braunstein, Carolyn A. Wilson   +2 more
doaj   +1 more source

Antibody affinity maturation and plasma IgA associate with clinical outcome in hospitalized COVID-19 patients

Nature Communications, 2021
SARS-CoV2 infection has been linked to a wide range of clinical severities and the immunopathology is still under intense scrutiny. Here, the authors uncover an association of antibody affinity maturation and plasma IgA levels with clinical outcome in ...
Juanjie Tang, Supriya Ravichandran, Youri Lee, Gabrielle Grubbs, Elizabeth M. Coyle, Laura Klenow, Hollie Genser, Hana Golding, Surender Khurana   +8 more
doaj   +1 more source

Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making

Реальная клиническая практика: данные и доказательства, 2023
In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions.
Ksenia S. Radaeva, M. V. Pchelintsev
doaj   +1 more source

Health‐Related Quality of Life and Symptom Severity Among Patients With PIK3CA‐Related Overgrowth Spectrum: A Mixed‐Methods Study to Understand Real‐World Experience With Alpelisib Treatment

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background PIK3CA‐related overgrowth spectrum (PROS) includes several rare overgrowth disorders resulting from somatic gain‐of‐function mutations in PIK3CA. Despite treatment advances, including the recent approval of alpelisib for PROS in the United States, literature detailing the patient experience with PROS is limited.
Vamsi Bollu, Kaitlin LaGasse, Cory D. Saucier, Kimberly Raymond, Miranda Lauher‐Charest, Lauren Crowder, Beilei Cai, Mary Lisha Paul, Denise Adams   +8 more
wiley   +1 more source

FDA-approved compounds that show inhibition of osteosarcoma cell proliferation.

, 2018
FDA-approved compounds that show inhibition of osteosarcoma cell proliferation.
Melinda Broward (3233358), Douglas H. Thamm (311291), Joy M. Fulbright (5007380), Tyce Bruns (5007389), Tomoo Iwakuma (508731), Megan Ottomeyer (5007383), Alejandro Parrales (5007377), Anuradha Roy (630348), Scott J. Weir (2069470), Kathleen A. Neville (280552), Frank J. Shoenen (5007386), Peter McDonald (1580623)   +11 more
core   +1 more source

TRAIL‐PEG‐Apt‐PLGA nanosystem as an aptamer‐targeted drug delivery system potential for triple‐negative breast cancer therapy using in vivo mouse model

Molecular Oncology, EarlyView.
Aptamers are used both therapeutically and as targeting agents in cancer treatment. We developed an aptamer‐targeted PLGA–TRAIL nanosystem that exhibited superior therapeutic efficacy in NOD/SCID breast cancer models. This nanosystem represents a novel biotechnological drug candidate for suppressing resistance development in breast cancer.
Gulen Melike Demirbolat, Aslihan Kucuk, Omer Erdogan, Samed Ozer, Bensu Kozan, Tugba Cuceli, Erkan Gumus, Evrim Cevik, Ozge Cevik   +8 more
wiley   +1 more source

Valid cardiac biochemical markers. Part II

Кардиоваскулярная терапия и профилактика, 2020
This publication is a continuation of the review of cardiac biomarkers approved by the Food and Drug Administration (USA), including analysis of prospective research, clinical trials and meta-analyses.
N. G. Gumanova, M. V. Klimushina, N. L. Bogdanova, O. V. Stefanyuk, V. A. Metelskaya   +4 more
doaj   +1 more source

Dimethyl fumarate combined with cisplatin at subcytotoxic doses sensitizes cervical cancer toward ferroptosis and apoptosis through GSH restriction and p53 (re)activation

Molecular Oncology, EarlyView.
Dimethyl fumarate (DMF) reduces growth of HPV‐positive cervical cancer spheroids and induces ferroptosis in cervical cancer cells via blocking SLC7A11/Glutathione (GSH) axis. Combination of subcytotoxic doses of DMF and cisplatin (CDDP) further suppresses spheroid growth and drives cell death in 2D culture models.
Carolina Punziano, Giuseppina Minopoli, Simona Romano, Laura Marrone, Katia Aquilano, Maria Lina Tornesello, Raffaella Faraonio   +6 more
wiley   +1 more source