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- PMLiVE

Janet Woodcock

- PMLiVE

FDA to review restrictions on GSK’s diabetes drug Avandia

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

- 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

- 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

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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

- PMLiVE

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

New indication approved alongside companion diagnostic to detect gene mutation

- PMLiVE

GSK wins US approval for Seretide successor Breo Ellipta

FDA gives green light to COPD combination

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