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News Breaks
October 24, 2012
07:38 EDTARIAARIAD announces FDA acceptance of NDA filing for Ponatinib
ARIAD Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application for accelerated review of ARIADís investigational BCR-ABL inhibitor, ponatinib, in patients with resistant or intolerant chronic myeloid leukemia or Philadelphia-chromosome positive acute lymphoblastic leukemia. The FDA also has granted ARIADís request for Priority Review, which is given to investigational medicines that have the potential for providing significant improvement in the treatment, prevention, or diagnosis of a disease. The FDA has established an action date of March 27, 2013 under the Prescription Drug User Fee Act.
News For ARIA From The Last 14 Days
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October 24, 2014
07:37 EDTARIAARIAD announces CHMP adopts final opinion on Iclusig
ARIAD Pharmaceuticals announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted its final opinion on Iclusig following the recommendations made by the Pharmacovigilance Risk Assessment Committee earlier this month. The PRAC conducted an 11-month review of the available data on Iclusig and consulted with a scientific advisory group in oncology. This week, the EMA recommended that Iclusig continue to be used in accordance with its already approved indications as a treatment of certain leukaemias and confirmed that the benefit-risk profile of Iclusig continues to be positive in each of these indications. The EMA also recommended additional warnings in the European product information to minimize the risk of vascular events. The company said, "We are now well positioned to complete pricing and reimbursement negotiations in Europe and to ensure that Iclusig is available to appropriate Philadelphia-chromosome positive leukaemia patients."
October 10, 2014
12:11 EDTARIAOptions with increasing implied volatility
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09:00 EDTARIAOn The Fly: Pre-market Movers
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07:46 EDTARIAARIAD announces PRAC of EMA recommends Iclusig for continued EU use
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