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icosapent ethyl

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FDA clears Amgen’s Xgeva for rare bone condition

US approval provides alternative to surgery for use in giant cell tumour of the bone

- PMLiVE

FDA approves Sanofi’s four-in-one flu vaccine

But wants more safety data for hepatitis B vaccine from Dynavax

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FDA turns down tivozanib for kidney cancer

Agency describes data provided by Aveo Oncology and Astellas as "uninterpretable"

- PMLiVE

FDA panel says Avandia restrictions should be eased

Vote backs wider use of GSK's drug in diabetes

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FDA to review restrictions on GSK’s diabetes drug Avandia

Advisory committee to discuss re-analysis of diabetes drug’s safety data

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Regulatory struggles force Aveo to cut 140 jobs

Expects FDA rejection for tivozanib in kidney cancer

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FDA gives priority review status to BMS/ AZ’s metreleptin

Former obesity prospect has potential in the rare disease lipodystrophy

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FDA clears two GSK melanoma drugs

Tafinlar and Mekinist approved in the US along with companion diagnostic

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FDA gives Alexion’s metabolic drug breakthrough status

Reduces requirements for registration, potentially speeding up approval

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US FDA approves Roche’s assay as first blood test to diagnose diabetes

Will help catch diabetes early in country where seven million people are undiagnosed

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Merck & Co inches closer to US green light for insomnia drug

FDA panel backs suvorexant, although some concerns about high dosages

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J&J’s Simponi wins FDA approval in ulcerative colitis

Adds to rheumatoid arthritis, psoriatic arthritis and active ankylosing spondylitis indications in the US

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