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Lundbeck buoyed by Brintellix approval in US

FDA gives green light for to Cipralex/Lexapro successor in depression

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FDA gives green light to Roche for early Perjeta in breast cancer

Oncology drug can now be used before surgery in the US

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Intermune supports awareness efforts for IPF

Last week's IPF World Week saw the global patient community unite

Keith Webber leaves FDA for Perrigo

Switches regulatory agency for biopharma company

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EASD 2013: Sanofi justifies decision to withdraw US filing for Lyxumia

Takes issue with FDA's narrow risk-benefit focus

FDA takes ‘tailored’ approach to mobile app regulation

Issues final guidance on smartphone and tablet computer technology

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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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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

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Personalised understanding: oncology and orphan diseases

Improvements in our understanding of cancer are drawing the orphan drug and oncology worlds ever closer together

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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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