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  • FDA approves AbbVie’s Mavyret for hepatitis C europeanpharmaceuticalreview
    August 07, 2017
    The FDA has approved Mavyret to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis…
  • FDA advisers reject J&J rheumatoid arthritis drug pharmaphorum
    August 04, 2017
    The chances of Johnson & Johnson’s rheumatoid arthritis drug sirukumab getting approved in the US look slim, after the FDA’s expert advisers raised concerns about its safety.
  • FDA green lights first treatment for chronic GvHD pharmatimes
    August 04, 2017
    The US Food and Drug Administration has expanded the scope of Johnson & Johnson/AbbVie’s Imbruvica to include the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments...
  • FDA Approves Chronic Graft Versus Host Disease Treatment americanpharmaceuticalreview
    August 04, 2017
    The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments.
  • FDA Approves Vyxeos drugs.com
    August 04, 2017
    FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
  • FDA Approves Mavyret contractpharma
    August 04, 2017
    FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C
  • FDA grants fast review to AZ cancer drug pharmaphorum
    August 03, 2017
    The FDA is to give AstraZeneca’s cancer drug acalabrutinib a fast review in a rare blood cancer, as the company hopes to shake off disappointing results from a crucial lung cancer trial last week.
  • FDA grants priority review to AstraZeneca's filing for BTK inhibitor acalabrutinib in mantle cell ly firstwordpharma
    August 03, 2017
    AstraZeneca announced Wednesday that the FDA accepted and granted priority review to an application seeking approval of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease drugs.com
    August 03, 2017
    The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy f
  • FDA approves Celgene and Agios' acute myeloid leukaemia drug pharmafile
    August 03, 2017
    The FDA has given its approval for the commercialisation of Celgene and Agios Pharmaceutical’s Idhifa for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients with an IDH2 mutation, it has emerged.

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