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  • 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...
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  • CMS Takes Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment

    Centers for Medicare and Medicaid Services Takes Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment | site |


    (November 10 - 13, 2020) - - In a release dated November 10, 2020 and updated November 13, 2020, the Centers for Medicare and Medicaid Services (CMS) published the following information: The Centers for Medicare & Medicaid Services announced that starting today, Medicare beneficiaries can receive coverage of monoclonal antibodies to treat coronavirus disease 2019 (COVID-19) with no cost-sharing during the public health emergency (PHE). CMS’ coverage of monoclonal antibody infusions applies to bamlanivimab, which received an emergency use authorization (EUA) from the U.S. Food and Drug Administration yesterday. “Today, CMS is announcing a historic, first-of-its kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost sharing,” said CMS Administrator Seema Verma. “Our tim...
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  • Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

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



    (November 9, 2020) - - On November 9, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima
    ...
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  • FDA Approves First Treatment for COVID-19

    FDA Approves First Treatment for COVID-19

    U.S. Food and Drug Administration Approves First Treatment for COVID-19 | site |




    (October 22, 2020) - - Today, October 22, 2020, the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered und
    ...
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  • NIH begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19

    National Institutes of Health begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19 | site |





    (October 16, 2020) - - Today, October 16, 2020, The National Institutes of Health (NIH) published the following information:

    The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive
    Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Graphic courtesy NIAID
    amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome,...
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  • U.S. Food and Drug Administration Approves First Treatment for Ebola Virus

    U.S. Food and Drug Administration Approves First Treatment for Ebola Virus

    U.S. Food and Drug Administration Approves First Treatment for Ebola Virus | site |


    (October 14, 2020) - - The U.S. Food and Drug Administration (FDA) published today, October 14, 2020, the following information:

    Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.

    “Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats—both domestically and abroad—on the basis of science and data,” said FDA Commissioner Stephen M. Hahn, M.D. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”

    Zaire ebolavirus, commonly known as Ebola virus, is one
    ...
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  • Health and Human Services Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19

    U.S. Department of Health and Human Services Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19 | site |



    (March 21, 2020) - - Today (March 21, 2020), the U.S. Department of Health and Human Services (HHS) published the following information:

    An antibody medicine being evaluated to treat severe cases of coronavirus disease 2019 (COVID-19) will receive additional support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) under an existing partnership with Regeneron Pharmaceuticals of Tarrytown, New York.

    The Biomedical Advanced Research and Development Authority (BARDA) within ASPR will provide support for a U.S. Phase 2/3 clinical trial to evaluate Kevzara as a potential treatment for severely ill COVID-19 patients. Currently, Kevzara is approved by the U.S. Food and Drug Administration for the treatment of rheumatoid arthritis. Kevzara was developed
    ...
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  • FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases

    U.S. Food and Drug Administration Approves First Treatment for Group of Progressive Interstitial Lung Diseases| site |



    (March 9, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.

    “The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases
    ...
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  • United Nations says UN Health Agency developing COVID-19 Virus Treatment Master Plan

    United Nations says UN Health Agency developing COVID-19 Virus Treatment Master Plan| site |




    (February 12, 2020) - - Today, the United Nations (UN) published the following information:


    The World Health Organization (WHO) is developing a master plan for coordinating clinical trials that could lead to potential therapies for patients infected with the COVID-19 virus, the agency’s chief, Tedros Adhanom Ghebreyesus, announced on Wednesday.


    Mr. Tedros was speaking at a press conference in Geneva, at the conclusion of a two-day research and innovation forum on COVID-19, during which leading health experts from around the world met to assess the current level of knowledge about the new disease, identify gaps and work together, so that critical research can begin immediately. These include decisions surrounding easy to apply diagnostics, the best approaches for infection prevention, potential therapies that could be us...
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  • U.S. Department of Veterans Affairs announces Proposed Rule regarding Equal Treatment of Faith-based organizations in VA-supported Social Service Programs

    U.S. Department of Veterans Affairs announces Proposed Rule regarding Equal Treatment of Faith-based organizations in VA-supported Social Service Programs| site |




    (January 16, 2020) - - Today, the U.S. Department of Veterans Affairs published the following information:

    WASHINGTON – The U.S. Department of Veterans Affairs (VA) proposed a rule, Jan. 16, that would implement President Trump’s, May 3, 2018, Executive Order (EO) establishing a White House Faith and Opportunity Initiative, to remove regulatory barriers allowing religious and non-religious organizations equal treatment in VA-supported social service programs. The proposed rule ensures VA-supported social service programs are implemented in a manner consistent with the Constitution and other applicable federal law. Under current regulations governing these programs, religious providers of social services — but not other providers of social services — must make referrals und...
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  • U.S. Secretary of Education Betsy DeVos Announces Proposed Rule Regarding Equal Treatment of Faith-Based Education Institutions, Provides Updated School Prayer Guidance

    U.S. Secretary of Education Betsy DeVos Announces Proposed Rule Regarding Equal Treatment of Faith-Based Education Institutions, Provides Updated School Prayer Guidance| site |



    (January 16, 2020) - - The U.S. Department of Education published (today) the following information:

    Washington — Today, U.S. Secretary of Education Betsy DeVos announced that the Department of Education is taking several concrete actions to protect religious liberty and ensure the Department is acting in accordance with the First Amendment. The Department announced a proposed rule ensuring the equal treatment and constitutional rights of religious organizations and faith-based institutions, as well as First Amendment freedoms owed to students on campus. As directed by Congress, the agency will also release updated guidance regarding constitutionally protected prayer in schools. "Our actions today will protect the constitutional rights of students, teachers, and faith-b
    ...
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  • Staff Reporter 1
    NIH says Fourth Iteration of COVID-19 Treatment Trial underway
    by Staff Reporter 1
    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...
    11-26-2020, 04:28 AM
  • Staff Reporter 1
    Decades of National Institutes of Health Research help lead to first FDA-approved Treatment for Progeria
    by Staff Reporter 1
    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
    ...
    11-24-2020, 04:11 AM
  • Staff Reporter 1
    FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
    by Staff Reporter 1
    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
    ...
    11-23-2020, 11:37 PM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
    by Staff Reporter 1
    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
    ...
    11-23-2020, 09:00 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19
    by Staff Reporter 1
    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...
    11-20-2020, 09:08 AM

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