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    Tag: u.s. food and drug administration

    You Searched For "US Food and Drug Administration"
    Pfizer Abrocitinib to treat atopic dermatitis meet goals in late-stage study

    Pfizer Abrocitinib to treat atopic dermatitis meet goals in late-stage study

    Garima18 May 2019 9:30 AM IST
    Abrocitinib, which belongs to a class of drugs known as JAK inhibitors, which block inflammation-causing enzymes, known as Janus kinases, achieved...
    Roche gets USFDA nod for combo drug Venclexta, Gazyva to treat lymphocytic leukaemia

    Roche gets USFDA nod for combo drug Venclexta, Gazyva to treat lymphocytic leukaemia

    Medical Dialogues Bureau17 May 2019 9:15 AM IST
    "Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without...
    Eli Lilly gets USFDA nod for Cyramza to treat hepatocellular carcinoma

    Eli Lilly gets USFDA nod for Cyramza to treat hepatocellular carcinoma

    Medical Dialogues Bureau14 May 2019 9:47 AM IST
    The USFDA has removed the boxed warning from the CYRAMZA labelling which highlighted warnings pertaining to haemorrhage, gastrointestinal perforation...
    Pfizer acquires clinical-stage Biotech Therachon for $810 million

    Pfizer acquires clinical-stage Biotech Therachon for $810 million

    Garima12 May 2019 9:45 AM IST
    NEW YORK: Pfizer recently announced that it has entered into a definitive agreement to acquire all the shares of Therachon Holding AG, a privately...
    Eli Lilly new migraine drug Emgality pulls ahead of Amgen in battle for prescriptions

    Eli Lilly new migraine drug Emgality pulls ahead of Amgen in battle for prescriptions

    Farhat Nasim12 May 2019 9:30 AM IST
    Weekly U.S. prescription data from IQVIA, an analytics provider to the life sciences industry, showed that Lilly's therapy Emgality claimed the...
    Following opioid suits, family behind deadly OxyContin squabbles

    Following opioid suits, family behind deadly OxyContin squabbles

    Medical Dialogues Bureau11 May 2019 9:00 AM IST
    NEW YORK: A united front among members of the billionaire Sackler family behind painkiller OxyContin is showing signs of strain from litigation over...
    Unichem Labs gets tentative USFDA nod for generic version of JnJ Zyrtec-D 12 Hour

    Unichem Labs gets tentative USFDA nod for generic version of JnJ Zyrtec-D 12 Hour

    Farhat Nasim9 May 2019 10:15 AM IST
    Unichem Lab's approved drug is a generic copy of Zyrtec-D 12 Hour which is used for treating allergic rhinitis.New Delhi: Unichem Laboratories Tuesday...
    Pfizer gets USFDA nod for potential blockbuster heart drug Tafamidis

    Pfizer gets USFDA nod for potential blockbuster heart drug Tafamidis

    Medical Dialogues Bureau7 May 2019 9:45 AM IST
    Pfizer, which has touted tafamidis as a potential blockbuster product, set a list price of $225,000 a year for the medicine, which would be sold under...
    AbbVie wins USFDA nod for Mavyret to treat HCV genotypes in pediatric patients

    AbbVie wins USFDA nod for Mavyret to treat HCV genotypes in pediatric patients

    Farhat Nasim3 May 2019 9:10 AM IST
    New Delhi: AbbVie Inc. recently won the U.S. Food and Drug Administration (USFDA) approval for Mavyret (glecaprevir and pibrentasvir) tablets to treat...
    USFDA declines to approve Nabriva

    USFDA declines to approve Nabriva's antibiotic Contepo for urinary tract infections

    Medical Dialogues Bureau1 May 2019 12:02 PM IST
    The U.S. Food and Drug Administration on Tuesday declined to approve Nabriva Therapeutics Plc's antibiotic Contepo for complicated urinary tract...
    Using AI to detect mental health disorders likely to be counterproductive

    Using AI to detect mental health disorders likely to be counterproductive

    Medical Dialogues Bureau30 April 2019 9:00 AM IST
    AI-based vocal analytics may allow patients to detect the disease at home by just speaking into a smartphone application, eliminating the need to be...
    Pfizer gets CHMP opinion for Talzenna for patients with metastatic breast cancer

    Pfizer gets CHMP opinion for Talzenna for patients with metastatic breast cancer

    Farhat Nasim29 April 2019 9:35 AM IST
    The positive CHMP opinion of TALZENNA follows the medicine's approval by the U.S. Food and Drug Administration (FDA) in October 2018.New Delhi:...
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