Results 31 to 40 of about 1,107,201 (376)

Review of Indications of FDA-Approved Immune Checkpoint Inhibitors per NCCN Guidelines with the Level of Evidence

open access: yesCancers, 2020
Cancer is associated with higher morbidity and mortality and is the second leading cause of death in the US. Further, in some nations, cancer has overtaken heart disease as the leading cause of mortality.
R. Vaddepally   +4 more
semanticscholar   +1 more source

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

open access: yesEuropean Journal of Health Economics, 2023
Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track ...
D. Michaeli   +4 more
semanticscholar   +1 more source

Repurposing ferumoxytol: Diagnostic and therapeutic applications of an FDA-approved nanoparticle

open access: yesTheranostics, 2022
Ferumoxytol is an intravenous iron oxide nanoparticle formulation that has been approved by the U.S. Food and Drug Administration (FDA) for treating anemia in patients with chronic kidney disease.
Yue Huang   +3 more
semanticscholar   +1 more source

FDA-approved disulfiram inhibits pyroptosis by blocking gasdermin D pore formation

open access: yesNature Immunology, 2020
Cytosolic sensing of pathogens and damage by myeloid and barrier epithelial cells assembles large complexes called inflammasomes, which activate inflammatory caspases to process cytokines (IL-1β) and gasdermin D (GSDMD).
J. Hu   +17 more
semanticscholar   +1 more source

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

open access: yesJournal 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   +2 more
doaj   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

open access: yes, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

open access: yesnpj Digital Medicine, 2020
At the beginning of the artificial intelligence (AI)/machine learning (ML) era, the expectations are high, and experts foresee that AI/ML shows potential for diagnosing, managing and treating a wide variety of medical conditions.
S. Benjamens   +2 more
semanticscholar   +1 more source

Current FDA-Approved Therapies for High-Grade Malignant Gliomas

open access: yesBiomedicines, 2021
The standard of care (SOC) for high-grade gliomas (HGG) is maximally safe surgical resection, followed by concurrent radiation therapy (RT) and temozolomide (TMZ) for 6 weeks, then adjuvant TMZ for 6 months. Before this SOC was established, glioblastoma (
Jacob P. Fisher, D. C. Adamson
semanticscholar   +1 more source

Identification of New Drug Candidates Against \u3cem\u3eBorrelia burgdorferi\u3c/em\u3e Using High-Throughput Screening [PDF]

open access: yes, 2016
Lyme disease is the most common zoonotic bacterial disease in North America. It is estimated that .300,000 cases per annum are reported in USA alone. A total of 10%–20% of patients who have been treated with antibiotic therapy report the recrudescence of
Babar, Mustafeez Mujtaba   +9 more
core   +3 more sources

FDA Approval Summary: Sotorasib for KRAS G12C Mutated Metastatic NSCLC.

open access: yesClinical Cancer Research, 2021
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C ...
Erica C Nakajima   +15 more
semanticscholar   +1 more source

Home - About - Disclaimer - Privacy