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- PMLiVE

Intellipharmaceutics

- PMLiVE

FDA gives Alexion’s metabolic drug breakthrough status

Reduces requirements for registration, potentially speeding up approval

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

FDA to review Merck & Co’s allergy immunotherapy

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

- PMLiVE

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

Vytorin extension wins FDA approval

- PMLiVE

FDA committee turns down Aveo/Astellas’ cancer drug

Tivozanib unable to prove superiority to Bayer's Nexavar

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