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- PMLiVE

Janet Woodcock

- PMLiVE

Bayer gets US nod for first-in-class Adempas

FDA clears drug for use in pulmonary artery hypertension

- PMLiVE

US shutdown “hurting business”

But FDA decisions continue to trickle through

- PMLiVE

Swift US approval for Baxter’s nutritional supplement

FDA backs Clinolipid to alleviate shortage of drugs for people unable to eat or drink

- PMLiVE

UCB wins extra Cimzia approval in US

FDA backs drug for use in patients with active psoriatic arthritis 

- 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

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