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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.
FDA approves new targeted treatment for acute myeloid leukemia europeanpharmaceuticalreview
August 03, 2017
The U.S. Food and Drug Administration has granted the approval of Idhifa to Celgene Corporation and RealTime IDH2 Assay to Abbott Laboratories…

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