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- PMLiVE

cerebral adrenoleukodystrophy

- PMLiVE

Regulatory struggles force Aveo to cut 140 jobs

Expects FDA rejection for tivozanib in kidney cancer

- PMLiVE

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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FDA clears Bayer/ Algeta’s prostate cancer radiotherapy

Approval for Xofigo comes three months ahead of schedule

- PMLiVE

Novo Nordisk: Strict US regulation threatens innovation

Warning from CEO Sorensen comes after Tresiba and Ryzodeg fail to win FDA approval

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FDA expands use of Roche/ Astellas’ Tarceva in lung cancer patients

New indication approved alongside companion diagnostic to detect gene mutation

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GSK wins US approval for Seretide successor Breo Ellipta

FDA gives green light to COPD combination

Novartis building

Novartis gets FDA green light for new Ilaris indication

Immunotherapeutic wins US approval for severe form of childhood arthritis

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