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- PMLiVE

Intellipharmaceutics

- PMLiVE

US shutdown threatens to disrupt FDA

Congress failure to agree budget cripples government functions

- PMLiVE

Lundbeck buoyed by Brintellix approval in US

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

- PMLiVE

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

Oncology drug can now be used before surgery in the US

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

- 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

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