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- PMLiVE

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Keith Webber leaves FDA for Perrigo

Switches regulatory agency for biopharma company

- PMLiVE

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

- PMLiVE

Generics industry pressures FDA over biosimilar naming standards

GPhA says biosimilars should carry same name as branded biologic medicines

- PMLiVE

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

- PMLiVE

Breakthrough status for GSK/ Genmab’s Arzerra

Speeds up FDA review for use in chronic lymphocytic leukaemia

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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

- 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

Amgen drug misses endpoint in acute heart failure trial

Company pledges to pursue development of omecamtiv mecarbil in chronic heart failure

- PMLiVE

FDA investigates safety of Novartis’ MS drug

Agency to determine association between Gilenya and rare brain infection

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