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13 For whosoever shall call upon the name of the Lord shall be saved. (Romans 10:13 - - - The Holy Bible)

Medicine

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  • U.S. Food and Drug Administration says Colorado Unapproved Drug and Dietary Supplement Makers Ordered to Cease Operations for Federal Violations

    U.S. Food and Drug Administration says Colorado Unapproved Drug and Dietary Supplement Makers Ordered to Cease Operations for Federal Violations





    Washington, DC - - (March 14, 2017) - - Today, the U.S. Food and Drug Administration published the following information: Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring Floren’s businesses to immediately cease opera...
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  • U.S. Food and Drug Administration Approves First Treatment for Frequent Urination at Night due to Overproduction of Urine

    U.S. Food and Drug Administration Approves First Treatment for Frequent Urination at Night due to Overproduction of Urine



    March 3, 2017


    The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition. “Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton
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  • Mutual Recognition Promises New Framework for Pharmaceutical Inspections for United States and European Union

    Mutual Recognition Promises New Framework for Pharmaceutical Inspections for United States and European Union





    March 2, 2017


    The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities. The amended agreement ‎represents the culmination of nearly three years of U.S. Food and Dr
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  • U.S. Food and Drug Administration Approves Odactra for House Dust Mite Allergies

    U.S. Food and Drug Administration Approves Odactra for House Dust Mite Allergies

    U.S. Food and Drug Administration Approves Odactra for House Dust Mite Allergies




    March 1, 2017


    The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age. “House dust mite allergic disease can negatively impact a person’s quality of life,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Researc
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  • U.S. Department of Veterans Affairs Study Highlights Benefits of Enhanced Aspirin in Preventing Certain Cancers

    U.S. Department of Veterans Affairs Study Highlights Benefits of Enhanced Aspirin in Preventing Certain Cancers





    March 3, 2017


    Washington, DC - - (March 1, 2017) - - Researchers know of aspirin’s benefits in preventing certain ailments — from cardiovascular disease to most recently colorectal cancer. But while the link to those two conditions was made, researchers also questioned how and if this “wonder drug” could work to ward
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  • U.S. Food and Drug Administration Approves Xermelo for Carcinoid Syndrome Diarrhea

    U.S. Food and Drug Administration Approves Xermelo for Carcinoid Syndrome Diarrhea

    U.S. Food and Drug Administration Approves Xermelo for Carcinoid Syndrome Diarrhea



    February 28, 2017


    Washington, DC - - (February 28, 2017) - - The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.

    Carcinoid syndrome is a cluster of symptoms
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  • U. S. Food and Drug Administration Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis

    U. S. Food and Drug Administration Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis



    February 27, 2017


    Washington, DC - - (February 23, 2017) - - The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s
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  • U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results

    U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results




    February 27, 2017


    Washington, DC - - (February 23, 2017) - - The U.S. Food and Drug Administration (FDA) today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide
    ...
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  • U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results

    U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results




    February 27, 2017


    Washington, DC - - (February 23, 2017) - - The U.S. Food and Drug Administration (FDA) today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide
    ...
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  • U.S. Food and Drug Administration Approves New Psoriasis Drug

    U.S. Food and Drug Administration Approves New Psoriasis Drug

    U.S. Food and Drug Administration Approves New Psoriasis Drug






    February 16, 2017


    Washington, DC - - (February 15, 2017) - - The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light treatment) and have failed to respond, or have stopped responding to other systemic therapies. "Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfo
    ...
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