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    Tag: usfda

    You Searched For "usfda"
    Loxo,Bayer gets U.S approval for cancer drug Larotrectinib

    Loxo,Bayer gets U.S approval for cancer drug Larotrectinib

    Medical Dialogues Bureau28 Nov 2018 9:06 AM IST
    New Delhi: A Loxo Oncology Inc drug larotrectinib shown to be effective against a wide variety of cancers driven by a single, rare genetic mutation...
    Indoco Remedies gets two minor observations from USFDA for Goa plants

    Indoco Remedies gets two minor observations from USFDA for Goa plants

    Medical Dialogues Bureau25 Nov 2018 9:07 AM IST
    Mumbai: Drug firm Indoco Remedies on Thursday said it has received two minor observations from the US health regulator for its Goa-based two plants....
    Lupin launches generic Tetrabenazine Tablets

    Lupin launches generic Tetrabenazine Tablets

    Medical Dialogues Bureau22 Nov 2018 4:26 PM IST
    Mumbai: Pharma major Lupin announced the launch of Tetrabenazine Tablets, 12.5 mg and 25 mg having received an approval from the United States Food...
    FDA approves new blood cancer treatment from Pfizer

    FDA approves new blood cancer treatment from Pfizer

    Medical Dialogues Bureau22 Nov 2018 9:15 AM IST
    The U.S. Food and Drug Administration on Wednesday approved Pfizer Inc's drug to treat a form of blood cancer in newly diagnosed patients as a...
    US FDA to strictly monitor sale of flavoured e-cigarettes

    US FDA to strictly monitor sale of flavoured e-cigarettes

    Medical Dialogues Bureau10 Nov 2018 3:46 PM IST
    The new policy will apply to flavoured cartridge-style vaping products like Juul that have become popular among youths, not the open tank-style...
    FDA approves Pfizer

    FDA approves Pfizer's Lorbrena treatment for certain lung cancer patients

    Medical Dialogues Bureau7 Nov 2018 9:40 AM IST
    Lorbrena, known chemically as lorlatinib, received an accelerated approval, Pfizer said. Its continued approval may depend on verification of clinical...
    FDA grants priority review for Sanofi

    FDA grants priority review for Sanofi's dengue vaccine candidate

    Medical Dialogues Bureau4 Nov 2018 11:00 AM IST
    The vaccine, known as Dengvaxia in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European...
    FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

    FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

    Medical Dialogues Bureau4 Nov 2018 9:36 AM IST
    New Delhi: The U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during...
    Granules gets 2 observation by USFDA for U.S Unit

    Granules gets 2 observation by USFDA for U.S Unit

    Medical Dialogues Bureau30 Oct 2018 10:48 AM IST
    New Delhi: Pharma firm Granules through a recent regulatory filing announced its US subsidiary has received two observations from the US health...
    Hypoglycaemia, Mental Health Side Effects: Label side-effect warnings of Fluoroquinolone, DCGI tells Drugmakers

    Hypoglycaemia, Mental Health Side Effects: Label side-effect warnings of Fluoroquinolone, DCGI tells Drugmakers

    Medical Dialogues Bureau26 Oct 2018 11:04 AM IST
    Fluoroquinolones are antibiotics used to treat respiratory and urinary tract infections. These medicines include ciprofloxacin, gemifloxacin,...
    Trivitron Healthcare eyes Rs 750 crore revenue in Financial Year 2019

    Trivitron Healthcare eyes Rs 750 crore revenue in Financial Year 2019

    Medical Dialogues Bureau8 Oct 2018 10:25 AM IST
    New Delhi: Domestic medical devices maker Trivitron Healthcare is looking to clock revenue of around Rs 750 crore in the current fiscal year, as it...
    Sun Pharma and SPARC

    Sun Pharma and SPARC's XELPROS gets USFDA approval

    Medical Dialogues Bureau15 Sept 2018 4:32 PM IST
    US Food and Drug Administration (USFDA) has approved the SPARC new drug application of XELPROS, used to reduce glaucoma open-angle glaucoma or ocular...
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