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    Tag: fda

    You Searched For "FDA"
    Sandoz launches SYMJEPI Injection in US to help treat allergic reactions

    Sandoz launches SYMJEPI Injection in US to help treat allergic reactions

    Medical Dialogues Bureau13 July 2019 4:02 AM
    SYMJEPI is a small, single-dose, pre-filled syringe and device combination as an alternative to epinephrine auto-injectors for the emergency treatment...
    Swiss company Actelion moves US court against Natco Pharma over generic of its patented drug

    Swiss company Actelion moves US court against Natco Pharma over generic of its patented drug

    Medical Dialogues Bureau5 Jun 2019 6:57 AM
    Hyderabad: Swiss pharma company Actelion Pharmaceuticals Ltd has filed a petition in a US court alleging that Natco Pharma and its US partner Syneos...
    Pfizer epilepsy drug Lyrica fails in phase III trial

    Pfizer epilepsy drug Lyrica fails in phase III trial

    Medical Dialogues Bureau28 May 2019 3:30 AM
    New Delhi: Pfizer Inc. recently announced that a Phase 3 study to assess the use of LYRICA (pregabalin) as adjunctive therapy for epilepsy patients 5...
    Biocon, Mylan gets Canadian nod for biosimilar of cancer drug Herceptin

    Biocon, Mylan gets Canadian nod for biosimilar of cancer drug Herceptin

    Farhat Nasim23 May 2019 6:29 AM
    Ogivri is the first trastuzumab biosimilar approved in Canada and the second biosimilar from Biocon and Mylan's joint portfolio approved in the...
    Pfizer acquires clinical-stage Biotech Therachon for $810 million

    Pfizer acquires clinical-stage Biotech Therachon for $810 million

    Garima12 May 2019 4:15 AM
    NEW YORK: Pfizer recently announced that it has entered into a definitive agreement to acquire all the shares of Therachon Holding AG, a privately...
    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 4:15 AM
    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...
    Jacobus Pharma wins USFDA approval for Ruzurgi to treat rare autoimmune disorder

    Jacobus Pharma wins USFDA approval for Ruzurgi to treat rare autoimmune disorder

    Medical Dialogues Bureau7 May 2019 3:55 AM
    The drug, Ruzurgi, was approved for use in patients aged between 6 and 17, the FDA said Lambert-Eaton myasthenic syndrome, which affects about three...
    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 3:40 AM
    New Delhi: AbbVie Inc. recently won the U.S. Food and Drug Administration (USFDA) approval for Mavyret (glecaprevir and pibrentasvir) tablets to treat...
    Sanofi wins USFDA approval to sell dengue vaccine Dengvaxia in parts of US

    Sanofi wins USFDA approval to sell dengue vaccine Dengvaxia in parts of US

    Farhat Nasim2 May 2019 4:30 AM
    Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots...
    USFDA declines to approve Nabriva

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

    Medical Dialogues Bureau1 May 2019 6:32 AM
    The U.S. Food and Drug Administration on Tuesday declined to approve Nabriva Therapeutics Plc's antibiotic Contepo for complicated urinary tract...
    GSK gets USFDA nod for Benlysta to treat pediatric patients with lupus

    GSK gets USFDA nod for Benlysta to treat pediatric patients with lupus

    Medical Dialogues Bureau30 April 2019 3:45 AM
    New Delhi: GlaxoSmithKline (GSK) has won the US Food and Drug Administration's (USFDA) approval for its Benlysta (belimumab) intravenous (IV) infusion...
    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 3:30 AM
    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...
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