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Horizon Pharma

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Priority review for Roche’s Avastin in cervical cancer

Will speed up FDA assessment of oncology drug

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Otsuka and Lundbeck file Abilify follow-up in the US

Brexpiprazole to be reviewed for use in schizophrenia and major depressive disorder

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Sun Pharma recalls antidepressant in US

Withdraws more than 40,000 bottles of venlafaxine hydrochloride

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FDA sets out framework for rare childhood diseases

Wants to encourage more trial use of biomarkers and speedier approval timelines

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FDA to review Sanofi’s Lantus successor

Decision on company’s next generation insulin Toujeo expected early next year

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Amgen and Boehringer drugs win FDA breakthrough status

Leukaemia drug and Pradaxa antidote will benefit from accelerated regulatory processes

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Third time lucky as MannKind’s inhaled insulin is approved

US FDA backs new diabetes treatment Afrezza

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AZ needs more data on olaparib, says FDA panel

Agency advisers demands more safety information on ovarian cancer drug

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FDA adds blood clot warning to testosterone products

Warns of risk of developing deep vein thrombosis and pulmonary embolism

FDA shares new #socialmedia guidance

Latest recommendations cover Twitter, paid search links and correcting misinformation

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FDA approves Biogen Idec’s haemophilia drug

Eloctate now available to help control and prevent bleeding episodes

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FDA begins data initiative with millions of adverse event reports

Will provide web developers and others with access to large public health datasets

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