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Management: Food and Drug Administration (FDA)
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Total 1725 results found since Jan 2013.
FDA Clears Bivalent COVID-19 Boosters for Kids As Young As 5
The U.S. on Wednesday authorized updated COVID-19 boosters for children as young as 5, seeking to expand protection ahead of an expected winter wave.
Tweaked boosters rolled out for Americans 12 and older last month, doses modified to target today’s most common and contagious Omicron relative. While there wasn’t a big rush, federal health officials are urging that people seek the extra protection ahead of holiday gatherings.
Now the Food and Drug Administration has given a green light for elementary school-age kids to get the updated booster doses, too—one made by Pfizer for 5- to 11-year-olds, and a vers...
Source: TIME: Health - October 12, 2022 Category: Consumer Health News Authors: LAURAN NEERGAARD/AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news
Circulating immune cells with megakaryocyte signature in response to COVID-19 mRNA vaccination
Coronavirus disease 2019 (COVID-19) is a life-threatening systemic disease caused by the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). Faced with this public health emergency, the scientific community developed several vaccines. Among them, BNT162b2 (Pfizer/BioNTec) and mRNA-1273 (Moderna) are the first broad-spectrum application of mRNA-based vaccine technology, and Ad26.COV2.S (Johnson and Johnson) is an Adenoviral vector-based vaccine, which have been granted emergency use authorization by Food and Drug Administration (FDA).
Source: Thrombosis Research - October 5, 2022 Category: Hematology Authors: Taisuke Kanaji, Yosuke Morodomi, Sachiko Kanaji Tags: Letter to the Editors-in-Chief Source Type: research
A Review of Extracorporeal Blood Purification Techniques for the Treatment of Critically Ill Coronavirus Disease 2019 Patients
In late 2019, a novel betacoronavirus, later termed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was discovered in patients with an unknown respiratory illness in Wuhan, China. SARS-CoV-2 and the disease caused by the novel coronavirus, coronavirus disease 2019 (COVID-19), spread rapidly and resulted in the World Health Organization declaring a pandemic in March 2020. In a minority of patients infected with SARS-CoV-2, severe illness develops characterized by a dysregulated immune response, acute respiratory distress syndrome, and multisystem organ failure. Despite the development of antiviral and multiple...
Source: ASAIO Journal - October 1, 2022 Category: Medical Devices Tags: Review Source Type: research
Racial Disparities Between C-Reactive Protein and COVID-19 In-Hospital Outcomes
This study shows that there are racial differences in the acute inflammatory response to coronavirus disease 2019 (COVID- 19). They also found that Blacks hospitalized for COVID-19 were less likely to receive corticosteroids and remdesivir before Food and Drug Administration (FDA) emergency use of remdesivir and less likely to be enrolled in clinical trials.
Source: The American Journal of Medicine - September 27, 2022 Category: General Medicine Authors: Wenjin Sun Tags: Letter Source Type: research
Pfizer, Moderna Seek Approval of New COVID-19 Boosters for Children
MONDAY, Sept. 26, 2022 -- Both Pfizer and Moderna have asked the U.S. Food and Drug Administration to approve their updated coronavirus boosters for children.
The " bivalent " shots, like those that adults were able to start receiving this month,...
Source: Drugs.com - Pharma News - September 26, 2022 Category: Pharmaceuticals Source Type: news
Pfizer, Moderna Seek Approval of New COVID Boosters for Kids
MONDAY, Sept. 26, 2022 -- Both Pfizer and Moderna have asked the U.S. Food and Drug Administration to approve their updated coronavirus boosters for children.
The " bivalent " shots, like those that adults were able to start receiving this month,...
Source: Drugs.com - Daily MedNews - September 26, 2022 Category: General Medicine Source Type: news
Novel Proline derivatives for Treating COVID-19
Curr Med Chem. 2022 Sep 22. doi: 10.2174/0929867329666220922095343. Online ahead of print.ABSTRACTCOVID-19 is a contagious disease. Paxlovid, a combination of Nirmatrelvir and Ritonavir, was granted emergency use authorization by the United States Food and Drug Administration (FDA) for the treatment of COVID-19 on December 22, 2021. These are peptidomimetic coronavirus main protease inhibitors. Nirmatrelvir is a proline derivative. The present patent describes similar proline- like compounds, their preparation, use, and pharmaceutical composition, and treatment.PMID:36154584 | DOI:10.2174/0929867329666220922095343
Source: Current Medicinal Chemistry - September 26, 2022 Category: Chemistry Authors: Surya K De Source Type: research
Considerations and Challenges in the Remdesivir Covid-19 Pediatric Development Program
This article summarizes key issues and regulatory considerations involved in the RDV COVID-19 pediatric development program, including the evolution of the EUA issued for RDV as results from registrational studies became available, and discusses lessons learned. This article is protected by copyright. All rights reserved.PMID:36149807 | DOI:10.1002/jcph.2158
Source: The Journal of Clinical Pharmacology - September 23, 2022 Category: Drugs & Pharmacology Authors: Kirk Chan-Tack Mario Sampson Justin Earp Vikram Arya Lynne Yao John Alexander Ethan Hausman Yodit Belew Debra Birnkrant Kimberly Struble Source Type: research
Miniaturized Real-Time PCR systems for SARS-CoV-2 detection at the Point-of-Care
Clin Chim Acta. 2022 Sep 17:S0009-8981(22)01304-3. doi: 10.1016/j.cca.2022.09.014. Online ahead of print.ABSTRACTOver the past two years, SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus 2) infection has spread globally causing multi-organ disease and severely impacting the healthcare systems of all countries. Accordingly, the development of easy-to-access diagnostic devices has become essential to limit the effect of the virus worldwide. Real-Time PCR is considered the gold standard to identify SARS-CoV-2 infection due to high sensitivity, affordability, and capacity to detect low viral loads at early disease sta...
Source: International Journal of Clinical Chemistry - September 20, 2022 Category: Chemistry Authors: Valeria Garzarelli Maria Serena Chiriac ò Marco Cereda Isidora Autuori Francesco Ferrara Source Type: research
A feasibility study of Covid-19 detection using breath analysis by high-pressure photon ionization time-of-flight mass spectrometry
This study evaluated a simple, fast, non-invasive VOCs-based COVID-19 detection method and demonstrated that it has good sensitivity and specificity in distinguishing COVID-19 infected patients from controls. It has great potential for fast and accurate COVID-19 detection.
Source: Journal of Breath Research - September 11, 2022 Category: Respiratory Medicine Authors: Peize Zhang, Tantan Ren, Haibin Chen, Qingyun Li, Mengqi He, Yong Feng, Lei Wang, Ting Huang, Jing Yuan, Guofang Deng and Hongzhou Lu Source Type: research
Who should get the updated coronavirus vaccine booster now—and who should wait?
The US Centers for Disease Control and Prevention has this month greenlit the rollout of updated Covid-19 vaccine boosters, following the US Food and Drug Administration's authorization. These shots will replace the boosters previously offered in the US such that, for people 12 and older, being "up-to-date" with vaccines means having the new jab.
Source: CNN.com - Health - September 8, 2022 Category: Consumer Health News Source Type: news
