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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

Bayer symbol

Bayer moves closer to US approval of PAH drug riociguat

FDA panel votes unanimously in favour of hypertension treatment

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

Unable to recommend expanded use of tolvaptan

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GSK’s diabetes hope albiglutide delayed in US

FDA extends deadline to April 2014

Sanofi reception

FDA panel backs OTC use of Sanofi’s allergy drug

Says Nasacort AQ can be sold without prescription

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AZ inks $815m deal for FibroGen anaemia drug

Deal comes as company reveals second quarter performance

Actelion HQ Switzerland

Actelion to buy Ceptaris – if FDA backs its cancer treatment

Acquisition contingent on Valchlor approval in rare lymphoma

FDA grants priority review to pain drug

Mallinckrodt’s MNK-795 is intended for the management of moderate to severe acute pain

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AZ and BMS try again with Forxiga in the US

Pharma companies re-submit diabetes drug to the FDA for approval

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FDA panel fails to back new use for AbbVie’s Humira

Votes 12 to 1 against new use in spondyloarthritis

Biogen Idec building

Biogen Idec’s long-acting beta interferon moves ahead in MS

US and EU accept filings for long-acting multiple sclerosis drug Plegridy

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