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    Tag: usfda

    You Searched For "usfda"
    Pfizer epilepsy drug Lyrica fails in phase III trial

    Pfizer epilepsy drug Lyrica fails in phase III trial

    Medical Dialogues Bureau28 May 2019 9:00 AM IST
    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...
    Novartis wins USFDA approval for first PI3K inhibitor for breast cancer

    Novartis wins USFDA approval for first PI3K inhibitor for breast cancer

    Farhat Nasim27 May 2019 6:10 PM IST
    The drug, alpelisib, to be marketed under the brand name Piqray, belongs to a class of drugs known as PI3K inhibitors and is the first of its kind to...
    Novartis gets USFDA nod for over Rs 13 crore gene therapy Zolgensma

    Novartis gets USFDA nod for over Rs 13 crore gene therapy Zolgensma

    Farhat Nasim25 May 2019 10:00 AM IST
    The Food and Drug Administration on Friday approved the treatment, called Zolgensma, for all children under age 2 who are confirmed by a genetic test...
    Panacea Biotec gets USFDA nod for chemotherapy drug Azacitidine

    Panacea Biotec gets USFDA nod for chemotherapy drug Azacitidine

    Farhat Nasim22 May 2019 9:45 AM IST
    Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about USD 110 million in US markets as per IQVIA...
    Pfizer gets USFDA approval for Fragmin to treat blood clot in pediatric patients

    Pfizer gets USFDA approval for Fragmin to treat blood clot in pediatric patients

    Farhat Nasim19 May 2019 9:45 AM IST
    The efficacy of Fragmin in children was based on a single trial with 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary...
    Cipla gets no USFDA observations for Indore facility

    Cipla gets no USFDA observations for Indore facility

    Farhat Nasim18 May 2019 9:45 AM IST
    The US health regulator conducted a post-approval inspection at Cipla Ltd's Indore facility from 13th May to 17th May 2019. New Delhi: Drug firm Cipla...
    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...
    Shilpa Medicare gets USFDA nod for Irinotecan injection to treat cancer

    Shilpa Medicare gets USFDA nod for Irinotecan injection to treat cancer

    Farhat Nasim17 May 2019 1:45 PM IST
    Irinotecan injection is used in the treatment of patients with metastatic carcinoma of the colon or rectum, the company added. NEW DELHI: Shilpa...
    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...
    Zydus Cadila gets USFDA nod for Chlorthalidone tablets to treat high BP

    Zydus Cadila gets USFDA nod for Chlorthalidone tablets to treat high BP

    Farhat Nasim13 May 2019 10:31 AM IST
    Zydus Cadila said Chlorthalidone tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad.New Delhi: Drug...
    Certain Medtronic pacemaker batteries fail without warning; USFDA flags issue

    Certain Medtronic pacemaker batteries fail without warning; USFDA flags issue

    Farhat Nasim13 May 2019 9:33 AM IST
    New Delhi: US Food and Drug Administration (FDA) has recently issued safety alarm about premature battery depletion without warning patients or health...
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