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  • Coronavirus COVID-19 - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

    Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 9, 2021)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death d
    ...
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  • U.S. Department of Veterans Affairs says VA plays Crucial Role in COVID-19 Treatment Study

    U.S. Department of Veterans Affairs says VA plays Crucial Role in COVID-19 Treatment Study | site |



    (Information contained in U.S. Department of Veterans Affairs press release dated: January 19, 2021)

    Washington - - U.S. Department of Veterans Affairs (VA) researchers and Veteran volunteers from the Atlanta and San Antonio VA medical centers were part of a recently published study that yielded crucial insights into COVID-19 treatment.

    The study published Dec. 11, 2020, by the New England Journal of Medicine, showed the drugs baricitinib and remdesivir combined were far better at improving and reducing recovery time of COVID-19 patients than treatment with remdesivir alone. “Safe and effective vaccines for COVID-19 are being rolled out in VA and other health care settings, but finding treatments remains crucial,” said VA Secretary Robert Wilkie. “VA researchers and all the Veterans who volunteer for studies are contributing to steady p
    ...
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  • American Medical Association Statement on HHS Decision to remove Barriers for Opioid Treatment

    American Medical Association Statement on U.S. Department of Health and Human Services Decision to remove Barriers for Opioid Treatment| site |



    (Information contained in American Medical Association [AMA] press release dated: January 14, 2021)


    The following statement is attributable to:

    Patrice Harris, M.D., M.A. Chair, AMA Opioid Task Force Immediate Past President, American Medical Association “The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder. Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it. The AMA urged HHS to change the regulations last year in order to remove a major barrier to reducing the nationwide epidemic of drug-related overdose and death.
    ...
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  • HHS Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies

    U.S. Department of Health and Human Services Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies | site |
    • System helps doctors and patients find locations for COVID-19 outpatient treatment
    • Use of monoclonal antibody treatments could help reduce need for hospitalization in high-risk patients


    (Information contained in U.S. Department of Health and Human Services press release: January 11, 2021)

    A web-based COVID-19 outpatient treatment locator maintained by the U.S. Department of Health and Human Services (HHS) is now available to assist healthcare providers and patients in finding potential locations for treatment with monoclonal antibody therapeutics. These medicines are authorized for emergency use in treating patients with mild or moderate COVID-19 who are at high risk of developing severe symptoms and requiring hospitalization. "We are focused intently on supporting healthcare providers in their efforts to save liv
    ...
    See more | Go to post

  • Scientists say Stem Cell Treatment corrects Skull Shape and Restores Brain Function in Mouse Model of Childhood Disorder

    Scientists say Stem Cell Treatment corrects Skull Shape and Restores Brain Function in Mouse Model of Childhood Disorder | site |


    Scientists regenerate parts of the skull affected by craniosynostosis, a common birth defect.


    (Information contained in National Institutes of Health [NIH] press release: January 7, 2021)

    Using stem cells to regenerate parts of the skull, scientists corrected skull shape and reversed learning and memory deficits in young mice with craniosynostosis, a condition estimated to affect 1 in every 2,500 infants born in the United States, according to the Centers for Disease Control and Prevention. The only current therapy is complex surgery within the first year of life, but skull defects often return afterward. The study, supported by the National Institute of Dental and Craniofacial Research (NIDCR), could pave the way for more effective and less invasive therapies for children with craniosynostosis. The...
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  • HHS collaborates with Merck to continue the Development and Large-scale Manufacturing of Investigational COVID-19 Treatment

    U.S. Department of Health and Human Services collaborates with Merck to continue the Development and Large-scale Manufacturing of Investigational COVID-19 Treatment | site |




    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 23, 2020)



    HHS, DOD collaborate with Merck to continue the development and large-scale manufacturing of investigational COVID-19 treatment

    The U.S. Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19. The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive ...
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  • U.S. Department of Agriculture Announces Joint Final Rule Regarding Equal Treatment of Faith-Based Organizations USDA-Supported Social Service Programs

    U.S. Department of Agriculture Announces Joint Final Rule Regarding Equal Treatment of Faith-Based Organizations USDA-Supported Social Service Programs | site |



    (Information contained in U.S. Department of Agriculture [USDA] press release: December 14, 2020) (Washington, D.C., December 14, 2020) – Today, the U.S. Department of Agriculture (USDA) announced a joint final rule with eight other Agencies—the Department of Justice, the Department of Homeland Security, the Department of Labor, the Department of Education, the Department of Health and Human Services, the Department of Housing and Urban Development, the Agency for International Development, and the Department of Veterans Affairs—to implement President Trump’s Executive Order No. 13831, on the Establishment of a White House Faith and Opportunity Initiative (May 3, 2018). This rule ensures that religious and non-religious organizations are treated equally in USDA-supported programs, and it clar...
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  • DHS Announces Joint Final Rule Regarding Equal Treatment of Faith-Based Organizations in DHS-Supported Social Service Programs

    U.S. Department of Homeland Security Announces Joint Final Rule Regarding Equal Treatment of Faith-Based Organizations in DHS-Supported Social Service Programs | site |


    (Information contained in U.S. Department of Homeland Security press release: December 14, 2020) Today, December 14, 2020, the Department of Homeland Security (DHS) announced a joint final rule with eight other Agencies—the Department of Justice, the Department of Labor, the Department of Education, the Department of Health and Human Services, the Department of Housing and Urban Development, the Department of Agriculture, the Agency for International Development, and the Department of Veterans Affairs—to implement President Trump’s Executive Order No. 13831, on the Establishment of a White House Faith and Opportunity Initiative (May 3, 2018). This rule ensures that religious and non-religious organizations are treated equally in DHS-supported programs, and it clarifies that religious organizatio...
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  • U.S. Department of Labor announces Joint Final Rule regarding Equal Treatment of Faith-based Organizations in Department of Labor-supported Social Service Programs

    U.S. Department of Labor announces Joint Final Rule regarding Equal Treatment of Faith-based Organizations in Department of Labor-supported Social Service Programs | site |



    (Information contained in U.S. Department of Labor press release: December 14, 2020) Washington, DC - - Today, the U.S. Department of Labor announced a joint final rule with eight other Agencies – the Department of Justice, the Department of Homeland Security, the Department of Education, the Department of Health and Human Services, the Department of Housing and Urban Development, the Department of Agriculture, the Agency for International Development and the Department of Veterans Affairs – to implement President Trump’s Executive Order No. 13831, on the Establishment of a White House Faith and Opportunity Initiative (May 3, 2018). This rule ensures that religious and non-religious organizations are treated equally in Department of Labor-supported programs, and it clar...
    See more | Go to post

  • U.S. Department of Education Announces Joint Final Rule Regarding Equal Treatment of Faith-Based Organizations in Department-Supported Social Service Programs

    U.S. Department of Education Announces Joint Final Rule Regarding Equal Treatment of Faith-Based Organizations in Department-Supported Social Service Programs| site |


    (Information contained in U.S. Department of Education press release: December 14, 2020) Washington - - Today, December 14, 2020, the Department of Education announced a joint final rule with eight other agencies — the Department of Justice, the Department of Homeland Security, the Department of Labor, the Department of Health and Human Services, the Department of Housing and Urban Development, the Department of Agriculture, the Agency for International Development, and the Department of Veterans Affairs — to implement President Trump’s Executive Order No. 13831, on the Establishment of a White House Faith and Opportunity Initiative (May 3, 2018). This rule ensures that religious and non-religious organizations are treated equally in Department-supported programs, and it clar...
    See more | Go to post

  • NIH says Fourth Iteration of COVID-19 Treatment Trial underway

    NIH says Fourth Iteration of COVID-19 Treatment Trial underway

    National Institutes of Health says Fourth Iteration of COVID-19 Treatment Trial underway| site |


    (Information contained in National Institutes of Health [NIH] press release: November 25, 2020) The National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, today announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized adults with coronavirus disease 2019 (COVID-19) who require supplemental oxygen. The NIAID-sponsored trial will enroll up to 1,500 patients at approximately 100 sites in the United States and other countries. Participants will be assigned at random to one of two treatment arms of equal size. One group will receive both dexamethasone, a corticosteroid available as a generic drug, and remdesivir, a broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc., of Foster City, California. Remdesivir, also known as Veklury, was r...
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  • Decades of National Institutes of Health Research help lead to first FDA-approved Treatment for Progeria

    Decades of National Institutes of Health Research help lead to first FDA-approved Treatment for Progeria | site |


    (Information included in a National Institutes of Health [NIH] news release media advisory: November 23, 2020)

    The U.S. Food and Drug Administration has approved the first treatment for progeria, a rare and fatal pediatric disease, characterized by dramatic, rapid aging beginning in childhood. The treatment was made possible thanks in part to work at the National Institutes of Health over nearly two decades to identify and understand the function of the mutant gene and the protein it encodes (called progerin), with the goal of identifying new therapeutic drugs for the disorder. Progeria, also known as Hutchinson-Gilford progeria syndrome, is a rare, multisystemic disease that causes premature aging and premature death in children. Progeria is caused by a genetic mutation in the LMNA (“lamin A”) gene, which helps maintain the normal
    ...
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  • FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

    FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

    U.S. Food and Drug Administration Expands Approval of Influenza Treatment to Post-Exposure Prevention | site |


    (Information contained in U.S. Food and Drug Administration press release: November 23, 2020)

    Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra
    ...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di
    ...
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  • Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19

    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |



    (Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)


    November 19, 2020


    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...
    See more | Go to post

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  • Staff Reporter 1
    Coronavirus COVID-19 - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 9, 2021)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death d
    ...
    02-10-2021, 06:46 AM
  • Staff Reporter 1
    U.S. Department of Veterans Affairs says VA plays Crucial Role in COVID-19 Treatment Study
    by Staff Reporter 1
    U.S. Department of Veterans Affairs says VA plays Crucial Role in COVID-19 Treatment Study | site |



    (Information contained in U.S. Department of Veterans Affairs press release dated: January 19, 2021)

    Washington - - U.S. Department of Veterans Affairs (VA) researchers and Veteran volunteers from the Atlanta and San Antonio VA medical centers were part of a recently published study that yielded crucial insights into COVID-19 treatment.

    The study published Dec. 11, 2020, by the New England Journal of Medicine, showed the drugs baricitinib and remdesivir combined were far better at improving and reducing recovery time of COVID-19 patients than treatment with remdesivir alone. “Safe and effective vaccines for COVID-19 are being rolled out in VA and other health care settings, but finding treatments remains crucial,” said VA Secretary Robert Wilkie. “VA researchers and all the Veterans who volunteer for studies are contributing to steady p
    ...
    01-20-2021, 09:37 AM
  • Staff Reporter 1
    American Medical Association Statement on HHS Decision to remove Barriers for Opioid Treatment
    by Staff Reporter 1
    American Medical Association Statement on U.S. Department of Health and Human Services Decision to remove Barriers for Opioid Treatment| site |



    (Information contained in American Medical Association [AMA] press release dated: January 14, 2021)


    The following statement is attributable to:

    Patrice Harris, M.D., M.A. Chair, AMA Opioid Task Force Immediate Past President, American Medical Association “The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder. Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it. The AMA urged HHS to change the regulations last year in order to remove a major barrier to reducing the nationwide epidemic of drug-related overdose and death.
    ...
    01-19-2021, 02:34 AM
  • Staff Reporter 1
    HHS Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies
    by Staff Reporter 1
    U.S. Department of Health and Human Services Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies | site |
    • System helps doctors and patients find locations for COVID-19 outpatient treatment
    • Use of monoclonal antibody treatments could help reduce need for hospitalization in high-risk patients


    (Information contained in U.S. Department of Health and Human Services press release: January 11, 2021)

    A web-based COVID-19 outpatient treatment locator maintained by the U.S. Department of Health and Human Services (HHS) is now available to assist healthcare providers and patients in finding potential locations for treatment with monoclonal antibody therapeutics. These medicines are authorized for emergency use in treating patients with mild or moderate COVID-19 who are at high risk of developing severe symptoms and requiring hospitalization. "We are focused intently on supporting healthcare providers in their efforts to save liv
    ...
    01-11-2021, 10:44 PM
  • Staff Reporter 1
    Scientists say Stem Cell Treatment corrects Skull Shape and Restores Brain Function in Mouse Model of Childhood Disorder
    by Staff Reporter 1
    Scientists say Stem Cell Treatment corrects Skull Shape and Restores Brain Function in Mouse Model of Childhood Disorder | site |


    Scientists regenerate parts of the skull affected by craniosynostosis, a common birth defect.


    (Information contained in National Institutes of Health [NIH] press release: January 7, 2021)

    Using stem cells to regenerate parts of the skull, scientists corrected skull shape and reversed learning and memory deficits in young mice with craniosynostosis, a condition estimated to affect 1 in every 2,500 infants born in the United States, according to the Centers for Disease Control and Prevention. The only current therapy is complex surgery within the first year of life, but skull defects often return afterward. The study, supported by the National Institute of Dental and Craniofacial Research (NIDCR), could pave the way for more effective and less invasive therapies for children with craniosynostosis. The...
    01-07-2021, 07:33 PM

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