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Management: Food and Drug Administration (FDA)

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Total 1725 results found since Jan 2013.

Biden Administration Plans for Booster Shot Campaign in September
A top F.D.A. regulator cited compelling data for redesigned coronavirus vaccines from Pfizer-BioNTech and Moderna.
Source: NYT - August 24, 2022 Category: American Health Authors: Sharon LaFraniere and Noah Weiland Tags: Coronavirus (2019-nCoV) Vaccination and Immunization Coronavirus Omicron Variant Food and Drug Administration Centers for Disease Control and Prevention Pfizer Inc Moderna Inc Fauci, Anthony S Marks, Peter Source Type: news

Treatment of Cushing ’s syndrome with osilodrostat: practical applications of recent studies with case examples
AbstractEndogenous Cushing ’s syndrome (CS) is a rare endocrine condition frequently caused by a tumor resulting in elevated cortisol levels. Cushing’s disease (CD) caused by an adrenocorticotropic hormone–secreting pituitary adenoma is the most common form of endogenous CS. Medical therapy for CD is mostly used as seco nd-line treatment after failed surgery or recurrence and comprises several pituitary-directed drugs, adrenal steroidogenesis inhibitors, and a glucocorticoid receptor blocker, some of which are US Food and Drug Administration (FDA)–approved for this condition. The recent Pituitary Society consensu s...
Source: Pituitary - August 24, 2022 Category: Endocrinology Source Type: research

The current status of COVID-19 vaccines. a scoping review
Drug Discov Today. 2022 Aug 19:S1359-6446(22)00306-3. doi: 10.1016/j.drudis.2022.08.004. Online ahead of print.ABSTRACTSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new disease that has led to a worldwide pandemic, resulting in millions of deaths and a high economic burden. Here, we analyze the current status of preventive vaccines authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Published clinical trials have shown the effectiveness of mRNA (BNT162b2 and Spikevax), adenovirus vector-based (Ad26.COV2.S and ChAdOx1 nCoV-19), and recombinant protein S (NVX-C...
Source: Drug Discovery Today - August 22, 2022 Category: Drugs & Pharmacology Authors: Manuel Rueda-Fern ández Luc ía Melguizo-Rodríguez V íctor J Costela-Ruiz Anabel Gonz ález-Acedo Javier Ramos-Torrecillas Rebeca Illescas-Montes Source Type: research

FDA authorizes Novavax Covid-19 vaccine for emergency use in ages 12-17
The US Food and Drug Administration authorized Novavax's Covid-19 vaccine on Friday for emergency use in adolescents. It is the fourth coronavirus vaccine available in the United States and, unlike the others, is uses a protein-based technology.
Source: CNN.com - Health - August 20, 2022 Category: Consumer Health News Source Type: news

News at a glance: Omicron vaccine, colonial-era exploitation, and mapping health equity
IN FOCUS Scientists rallied outside Canada’s Parliament on 11 August, carrying a 70-meter-long letter with more than 7000 signatures. The letter to lawmakers calls for increases in the stipends paid by graduate student scholarships and postdoctoral fellowships awarded by the Natural Sciences and Engineering Research Council of Canada. “We can’t do science if we can’t pay rent,” one rallygoer’s sign read. COVID-19 U.K. OKs anti-Omicron vaccine The United Kingdom this week became the first country to approve an updated COVID-19 booster directed at two different strains of the coronavi...
Source: ScienceNOW - August 18, 2022 Category: Science Source Type: news

British Regulators Authorize Moderna ’ s Updated COVID-19 Booster
LONDON — British drug regulators have become the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that aims to protect against the original virus and the Omicron variant. In a statement on Monday, the Medicines and Healthcare Regulatory Agency said it had given the green light to Moderna’s combination “bivalent” vaccine, which will be used as an adult booster shot. Each dose of the booster shot will target both the original COVID-19 virus that was first detected in 2020 and the Omicron BA.1 variant that was first picked up in November. British regulators said...
Source: TIME: Health - August 15, 2022 Category: Consumer Health News Authors: Maria Cheng/AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

COVID-19 vaccine uptake among Arkansas public K-12 school teachers and staff
Vaccine. 2022 Aug 2:S0264-410X(22)00942-2. doi: 10.1016/j.vaccine.2022.07.045. Online ahead of print.ABSTRACTIn December 2020, the first coronavirus disease 2019 (COVID-19) vaccines received emergency use authorization from the Food and Drug Administration (FDA). To strategically allocate the limited availability of COVID-19 vaccines, the Advisory Committee on Immunization Practices (ACIP) developed a phased approach for eligibility that prioritized certain population groups that were more vulnerable to infection and severe outcomes. Public K-12 teachers and staff were included in Phase 1b. The Arkansas Department of Healt...
Source: Vaccine - August 14, 2022 Category: Allergy & Immunology Authors: Michael J Cima Donald McCormick Austin Porter Namvar Zohoori Scott Alsbrook Jos é R Romero Source Type: research

People Exposed to Coronavirus May Need to Take as Many as Three At-Home Tests, F.D.A. Says
Repeat tests, spaced two days apart, reduce the odds of false negative results, the agency noted.
Source: NYT Health - August 12, 2022 Category: Consumer Health News Authors: Emily Anthes Tags: your-feed-science your-feed-health Coronavirus (2019-nCoV) Tests (Medical) Coronavirus Omicron Variant Food and Drug Administration Source Type: news

What the New C.D.C. Guidelines Mean for You
The new recommendations put the onus on individuals to protect themselves. Here ’s how to navigate them.
Source: NYT Health - August 12, 2022 Category: Consumer Health News Authors: Emily Anthes Tags: your-feed-science Coronavirus (2019-nCoV) Quarantines Tests (Medical) Centers for Disease Control and Prevention Masks Vaccination and Immunization Contact Tracing (Public Health) Education (K-12) Food and Drug Administration Source Type: news

Advances in delivery methods of < em > Arthrospira platensis < /em > (spirulina) for enhanced therapeutic outcomes
Bioengineered. 2022 Jun;13(6):14681-14718. doi: 10.1080/21655979.2022.2100863.ABSTRACTArthrospira platensis (A. platensis) aqueous extract has massive amounts of natural products that can be used as future drugs, such as C-phycocyanin, allophycocyanin, etc. This extract was chosen because of its high adaptability, which reflects its resolute genetic composition. The proactive roles of cyanobacteria, particularly in the medical field, have been discussed in this review, including the history, previous food and drug administration (FDA) reports, health benefits and the various dose-dependent therapeutic functions that A. pla...
Source: Cell Research - August 10, 2022 Category: Cytology Authors: Omar Ashraf ElFar Nashiru Billa Hooi Ren Lim Kit Wayne Chew Wai Yan Cheah Heli Siti Halimatul Munawaroh Deepanraj Balakrishnan Pau Loke Show Source Type: research

Viruses, Vol. 14, Pages 1734: Ionophore Antibiotics Inhibit Type II Feline Coronavirus Proliferation In Vitro
This study shows that ionophore antibiotics, including valinomycin, salinomycin, and nigericin, inhibit FCoV proliferation in vitro in a dose-dependent manner. These results suggest that ionophore antibiotics should be investigated further as potential broad-spectrum anti-FCoV agents.
Source: Viruses - August 6, 2022 Category: Virology Authors: Yoshikazu Tanaka Eri Tanabe Yuki Nonaka Mitsuki Uemura Tsuyoshi Tajima Kazuhiko Ochiai Tags: Article Source Type: research

Treatment of Multiple Sclerosis
PURPOSE OF REVIEW Given the expansion of options for the treatment of relapsing multiple sclerosis, this review outlines the framework for developing a treatment strategy, with consideration of when to switch or discontinue therapies, and a comprehensive elaboration of the mechanisms of action, efficacy, and safety considerations for each of the therapeutic classes. RECENT FINDINGS The armamentarium of immunotherapies has grown rapidly, to encompass 19 US Food and Drug Administration (FDA)-approved immunotherapies available in 2021, which are addressed in the review. The coronavirus pandemic that began in 2020 u...
Source: CONTINUUM: Lifelong Learning in Neurology - August 1, 2022 Category: Neurology Tags: REVIEW ARTICLES Source Type: research