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  • U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder

    U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder | site |


    Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020) Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative. “The approval of Oxlumo represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” said Norman Stockbridge, M.D., Ph.D., director of the ...
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  • HHS Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19

    U.S. Department of Health and Human Services Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19 | site |


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

    The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.

    In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health
    ...
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  • FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

    U.S. Food and Drug Administration Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs| site |


    (November 16, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information: Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog’s skin (subcutaneous), in particular areas of a dog’s leg. Stelfonta is injected directly into the MCT (intratumoral injection). Stelfonta works by activating a protein that spreads throughout the treated tumor, which disintegrates tumor cells. “This is the first approval for an intratumoral injection to treat non-metastatic mast cell tumors in dogs,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “This appro...
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  • HHS allocates Lilly therapeutic to treat Patients with Mild to Moderate COVID-19

    HHS allocates Lilly therapeutic to treat Patients with Mild to Moderate COVID-19

    U.S. Department of Health and Human Services allocates Lilly therapeutic to treat Patients with Mild to Moderate COVID-19 | site |




    (November 10, 2020) - - Today the U.S. Department of Health and Human Services (HHS) published the following information:

    The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Eli Lilly and Company’s investigational monoclonal antibody therapeutic, bamlanivimab, which received emergency use authorization from the U.S. Food and Drug Administration November 9 for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19.

    On October 28, the federal government announced a purchase of 300,000 doses of bamlanivimab. HHS will allocate these doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug. The federal government can purchase up to 650,000 additional
    ...
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  • FDA Approves Lotion for Nonprescription Use to Treat Head Lice

    FDA Approves Lotion for Nonprescription Use to Treat Head Lice

    U.S. Food and Drug Administration Approves Lotion for Nonprescription Use to Treat Head Lice| site |



    (October 27, 2020) - - The U.S. Food and Drug Administration (FDA) published today, October 27, 2020, the following information:

    Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.

    “The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another
    ...
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  • HHS says HHS and DOD Collaborate on Plans to Purchase of Lilly Investigational Therapeutic to Treat COVID-19 

    U.S. Department of Health and Human Services says HHS and DOD Collaborate on Plans to Purchase of Lilly Investigational Therapeutic to Treat COVID-19 | site |



    (October 28, 2020) - - Today, October 28, 2020. the U.S. Department of Health and Human Services published the following information:

    As part of the Trump Administration’s goal of delivering life-saving vaccines and therapeutics in record time through Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD exit disclaimer icon) today announced an agreement with Eli Lilly and Company to purchase the first doses of the company’s COVID-19 investigational antibody therapeutic bamlanivimab, also known as LY-CoV555. These doses will be available for patient care if the U.S. Food and Drug Administration (FDA) authorizes use of the therapeutic, as outlined in agency guidance. “This agreement with Eli Lilly is part of Operation Warp Speed’s e
    ...
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  • NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin plus Remdesivir to Treat COVID-19 Begins

    National Institutes of Health Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin plus Remdesivir to Treat COVID-19 Begins | site |


    Editor's note: Please note that this article was published on October 8, 2020

    (October 8, 2020) - - On October 8, 2020, the National Institutes of Health (NIH) published the following information:

    A clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, has begun. The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents. The National


    Graphic courtesy NIH/NIAID
    Institute of Allergy...
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  • National Institutes of Health Clinical Trial of Remdesivir to Treat COVID-19 Begins

    National Institutes of Health Clinical Trial of Remdesivir to Treat COVID-19 Begins | site |



    Study Enrolling Hospitalized Adults with COVID-19 in Nebraska



    (February 25, 2020) - - Today, the National Institutes of Health (NIH) published the following information: A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. This is the first clinical trial in the United States to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China. The first trial participant is an American who was repatriated after being quarantined...
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  • FDA Approves the first Targeted Therapy to Treat a Rare Mutation in Patients with Gastrointestinal Stromal Tumors

    U.S. Food and Drug Administration Approves the first Targeted Therapy to Treat a Rare Mutation in Patients with Gastrointestinal Stromal Tumors| site |




    (January 9, 2020) - - The U.S. Food and Drug Administration (FDA) published (today) the following information: Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach or small intestine – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keeps the cancer cells from growing. ...
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  • FDA Approves First Targeted Therapy to Treat Patients with Painful Complication of Sickle Cell Disease

    U.S. Food and Drug Administration Approves First Targeted Therapy to Treat Patients with Painful Complication of Sickle Cell Disease | site |



    (November 15, 2019) - - The U.S. Food and Drug Administration (FDA) published (today) the following information: Today, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older. “Hope has never been higher for people living with sickle cell disease and their families and supporters, with a pipeline of new treatments on the horizon, like the one being approved today, and several initiatives underway to better utilize current tools in the battle against the painful and deadly blood disorder,” said Acting FDA Commissioner Adm. Brett P. Giroir, M.D. “The opportunity
    ...
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  • Federal Trade Commission Brings First-ever Action Targeting “iV Cocktail” Therapy Marketer

    Federal Trade Commission Brings First-ever Action Targeting “iV Cocktail” Therapy Marketer




    Order settling complaint bars Texas-based firm and owner from making unsupported claims that iV cocktails can treat serious diseases and produce fast, long-lasting results



    The Federal Trade Commission today, for the first time, charged a marketer and seller of intravenously injected therapy products (iV Cocktails) with making a range of deceptive and unsupported health claims about their ability to treat serious diseases such as cancer, multiple sclerosis, and congestive heart failure.

    The proposed FTC order settling the claims prohibits the company, which operates a string of clinics in north Texas; New Braunfels, Texas; and Vail, Colorado, and its owner from making such claims, unless they can be supported by competent and reliable scientific evidence. T
    ...
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  • Staff Reporter 1
    U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder | site |


    Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020) Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative. “The approval of Oxlumo represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” said Norman Stockbridge, M.D., Ph.D., director of the ...
    11-24-2020, 11:35 AM
  • Staff Reporter 1
    HHS Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19
    by Staff Reporter 1
    U.S. Department of Health and Human Services Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19 | site |


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

    The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.

    In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health
    ...
    11-23-2020, 11:16 PM
  • Staff Reporter 1
    FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs| site |


    (November 16, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information: Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog’s skin (subcutaneous), in particular areas of a dog’s leg. Stelfonta is injected directly into the MCT (intratumoral injection). Stelfonta works by activating a protein that spreads throughout the treated tumor, which disintegrates tumor cells. “This is the first approval for an intratumoral injection to treat non-metastatic mast cell tumors in dogs,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “This appro...
    11-16-2020, 08:35 PM
  • Staff Reporter 1
    HHS allocates Lilly therapeutic to treat Patients with Mild to Moderate COVID-19
    by Staff Reporter 1
    U.S. Department of Health and Human Services allocates Lilly therapeutic to treat Patients with Mild to Moderate COVID-19 | site |




    (November 10, 2020) - - Today the U.S. Department of Health and Human Services (HHS) published the following information:

    The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Eli Lilly and Company’s investigational monoclonal antibody therapeutic, bamlanivimab, which received emergency use authorization from the U.S. Food and Drug Administration November 9 for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19.

    On October 28, the federal government announced a purchase of 300,000 doses of bamlanivimab. HHS will allocate these doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug. The federal government can purchase up to 650,000 additional
    ...
    11-10-2020, 09:48 PM
  • Staff Reporter 1
    FDA Approves Lotion for Nonprescription Use to Treat Head Lice
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves Lotion for Nonprescription Use to Treat Head Lice| site |



    (October 27, 2020) - - The U.S. Food and Drug Administration (FDA) published today, October 27, 2020, the following information:

    Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.

    “The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another
    ...
    11-05-2020, 10:12 PM

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