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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

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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

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Novartis gets FDA green light for new Ilaris indication

Immunotherapeutic wins US approval for severe form of childhood arthritis

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FDA to review Merck & Co’s allergy immunotherapy

Accepts application for oral tablet to protect against ragweed-based allergies

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Merck & Co wins green light in US for Zetia-Lipitor combo

Vytorin extension wins FDA approval

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FDA committee turns down Aveo/Astellas’ cancer drug

Tivozanib unable to prove superiority to Bayer's Nexavar

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FDA says Janssen’s myeloma drug is a ‘breakthrough therapy’

Should speed up regulatory process for daratumumab

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GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

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FDA approves drugs for rare genetic liver condition and to reverse anticoagulation

Raptor’s Procysbi and CSL Behring’s Kcentra recommended in US

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