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- PMLiVE

Flatiron

- PMLiVE

FDA panel backs Perjeta in early breast cancer

Unanimous recommendation for use alongside Herceptin

- PMLiVE

FDA guidance clears path for Advair generics

Offers simplified process for potential copies of GSK’s asthma and COPD drug

- PMLiVE

Celgene wins US pancreatic cancer indication for Abraxane

Adds to breast cancer and lung cancer indications

- PMLiVE

FDA grants priority review to Takeda’s colitis drug

Accelerates review time for vedolizumab

- PMLiVE

FDA investigates safety of Novartis’ MS drug

Agency to determine association between Gilenya and rare brain infection

- PMLiVE

FDA turns down Otsuka’s kidney disease candidate

Requests additional information for tolvaptan

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EU nod for Bayer’s Stivarga as Nexavar gets US priority review

Advances pharma company’s ambitions in cancer

- PMLiVE

Novartis orphan drug wins ‘breakthrough’ status from FDA

Bimagrumab could be first treatment for rare life-threatening muscle-wasting condition

- PMLiVE

ViiV gets US nod for HIV drug dolutegravir

GSK and Pfizer joint venture on course for first drug launch

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Bayer moves closer to US approval of PAH drug riociguat

FDA panel votes unanimously in favour of hypertension treatment

- PMLiVE

FDA panel turns down Otsuka’s drug for rare kidney disease

Unable to recommend expanded use of tolvaptan

- PMLiVE

GSK’s diabetes hope albiglutide delayed in US

FDA extends deadline to April 2014

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