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FDA Priority Status


On January 15, 2015 Pernix Therapeutics excitedly announced an FDA acceptance for a priority review of Sumatriptan and Naproxen Sodium, also known as Treximet, for adolescent patients. Pernix expects an FDA approval by the second quarter of 2015, which would greatly benefit the adolescent patient population suffering from migraines. This anticipated approval would be specific[…]

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The early EU approval for Ibrutinib was granted by the European Commission (EC), for Ibrutinib to be sold in the 28 European Union (EU) member states. Ibrutinib is a first-in-class, oral, once-daily, non-chemotherapy treatment option, and will be used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).[…]

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On February 6, 2014 the FDA announced their decision to grant an acceptance to file and a Priority Review for Belinostat, also known as Beleodaq. As a pan-HDAC inhibitor, Belinostat is marketed by Topotarget, a Scandinavian based company. Comprehensive studies of Belinostat in patients with refractory and relapsed peripheral T-cell lymphoma {PTCL} have revealed extremely[…]

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On November 20, 2013 Health Canada revealed the approval of Simeprevir, known as the brand name GALEXOS, to treat hepatitis C. Janssen, the company that markets GALEXOS offered excitement for the approval of it’s once a day hepatitis C treatment. Simeprevir is designed to be administered adjunctively with both ribavirin and pegylated interferon, for the[…]

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Exciting new was recently revealed from Pharmacyclics, when it was announced that the New Drug Application for Ibrutinib was placed on a priority basis by the FDA. This NDA for Ibrutinib is applicable in two different oncology indications. The first indication for Ibrutinib is for patients with mantle cell lymphoma (MCL) who have received prior[…]

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