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- PMLiVE

etelcalcetide

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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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Research units to close as Astellas restructures

US subsidiaries OSI Pharmaceuticals and Perseid Therapeutics among those affected

- PMLiVE

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

Amgen forms joint venture in China to boost Vectibix

Partners with Zhejiang Beta Pharma on colon cancer drug

- 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

- PMLiVE

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

Should speed up regulatory process for daratumumab

- PMLiVE

GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

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