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Orgovyx

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Generics industry pressures FDA over biosimilar naming standards

GPhA says biosimilars should carry same name as branded biologic medicines

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Dendreon’s cancer vaccine wins EU approval

Provenge approved for use in prostate cancer three years after US recommendation

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This month in 2010: How one woman helped prevent a health crisis in the US

The FDA's Frances Oldham Kelsey honoured for her work to prevent the use of thalidomide

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Breakthrough status for GSK/ Genmab’s Arzerra

Speeds up FDA review for use in chronic lymphocytic leukaemia

Bristol-Myers Squibb (BMS) building

BMS’ Yervoy fails prostate cancer trial

Unable to improve overall survival in phase III

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FDA panel backs Perjeta in early breast cancer

Unanimous recommendation for use alongside Herceptin

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FDA guidance clears path for Advair generics

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

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Celgene wins US pancreatic cancer indication for Abraxane

Adds to breast cancer and lung cancer indications

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FDA grants priority review to Takeda’s colitis drug

Accelerates review time for vedolizumab

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FDA investigates safety of Novartis’ MS drug

Agency to determine association between Gilenya and rare brain infection

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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

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