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FDA grants orphan drug status to Inhibikase's imatinib to treat PMLThe US Food and Drug Administration (FDA) has granted orphan drug designation to Inhibikase Therapeutics' imatinib for treatment of progressive multifocal leukoencephalopathy (PML). PML is a rare sid2014/5/26
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Protalix gets marketing approval in Australia for ELELYSO to treat Gaucher diseaseIsrael-based biopharmaceutical firm Protalix BioTherapeutics has received approval from the Australian Therapeutic Goods Administration (TGA) for ELELYSO (taliglucerase alfa) for injection, as a long-2014/5/26
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Abbvie gets FDA orphan drug status for HUMIRA to treat non-infectious uveitisThe US Food and Drug Administration (FDA) has granted orphan drug designation for AbbVie's HUMIRA (adalimumab) to treat non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectiou2014/5/23
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Japanese Ministry grants orphan status to Edison's EPI-743 to treat Leigh syndromeThe Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan designation to Edison Pharmaceuticals' EPI-743, an orally bioavailable small molecule, being developed for the treatment o2014/5/23
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FDA grants breakthrough therapy status to BMS and AbbVie's myeloma drugUS-based pharmaceutical firms Bristol-Myers Squibb (BMS) and AbbVie have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for elotuzumab, an investigational hum2014/5/22
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US FDA approves Takeda's Entyvio to treat ulcerative colitis and Crohn's diseaseThe US Food and Drug Administration (FDA) has approved Japan-based Takeda Pharmaceutical Company and its US subsidiary's new biologic therapy, Entyvio (vedolizumab), for treating adults with moderatel2014/5/22
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Shire plans to seek FDA approval for dry eye drug in early 2015Ireland-based Shire is planning to submit a new drug application (NDA) for lifitegrast to the US Food and Drug Administration (FDA) in the first-quarter of 2015. The company is seeking FDA approval f2014/5/21
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European Commission approves simeprevir to treat hepatitis C genotype 1 and 4 infectionThe European Commission has granted marketing authorisation to simeprevir for the treatment of adults with genotype 1 and 4 chronic hepatitis C in combination with other medicinal products. Simeprevi2014/5/21
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Novartis fails to secure FDA approval for heart failure drug serelaxinSwiss pharmaceutical firm Novartis has failed to secure approval from the US Food and Drug Administration (FDA) for RLX030 (serelaxin), a relaxin receptor agonist, as a treatment for patients with acu2014/5/20
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FDA grants breakthrough therapy status to BMS's lymphoma drug nivolumabThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Bristol-Myers Squibb's (BMS) investigational PD-1 immune checkpoint inhibitor nivolumab to treat patients wit2014/5/20