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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

Boehringer Ingelheim headquarters

Boehringer submits COPD combo in EU

Combines Spiriva and Striverdi

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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

AZ expands its mHealth services with new COPD initiative

Partners with Exco InTouch to launch Me&MyCOPD programme

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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FDA fast-tracks new AstraZeneca antibiotic

Speeds up review period for AZD0914 in gonorrhoea

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