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- PMLiVE

Janet Woodcock

- PMLiVE

Third time lucky as MannKind’s inhaled insulin is approved

US FDA backs new diabetes treatment Afrezza

- PMLiVE

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

- PMLiVE

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

- PMLiVE

FDA fast-tracks new AstraZeneca antibiotic

Speeds up review period for AZD0914 in gonorrhoea

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Smaller companies driving innovation in pharma

IMS Health says specialty medicines are creating a level playing field

Novartis building

FDA rejects Novartis’ breakthrough heart failure drug

Regulator wants more data on serelaxin

- PMLiVE

FDA unveils new biosimilars guidance

Will clarify route to market for copies of biological drugs

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Amgen appoints ex US surgeon general

Steven Galson is also a former director of the FDA’s Center for Drug Evaluation and Research

- PMLiVE

Xtandi on course for pre-chemo use in prostate cancer

US FDA grants priority review to Medivation and Astellas drug

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