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- PMLiVE

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Pfizer gets FDA OK for expanded use of lung cancer drug Xalkori

First NSCLC treatment targeting the rare ROS1 mutation to be approved in the US

- PMLiVE

A better direction

Could behavioural science be the key to improving patient outcomes?

AstraZeneca AZ global R&D corporate HQ

AZ’s influenza drug fast tracked in US

FDA expedites MEDI8852 to help meet an acute need for new flu treatments

- PMLiVE

FDA clears Imbruvica as chemo alternative for first-line CLL

Johnson & Johnson/AbbVie's first-in-class drug now approved for all CLL patients

Roche Basel Switzerland

Roche chalks up second approval for Gazyva

FDA approves additional indication as a treatment for follicular lymphoma

- PMLiVE

US precision medicine push gathers momentum

Hopes to ‘revolutionise’ medicines through creation of shared healthcare databases

- PMLiVE

FDA rejects PTC’s application for muscular dystrophy drug

Says Translarna filing not “sufficiently complete” to permit full review

- PMLiVE

Dr Robert Califf confirmed as new head of the FDA

US Senate votes in favour of his appointment to lead the regulator

Novartis building

Novartis claims FDA breakthrough status for leukaemia treatment

Designation could speed up development and access for Novartis’ PKC412

- PMLiVE

Amgen says romosozumab on track for 2016 filing

Reports ‘significant’ reduction of fractures in post-menopausal osteoporosis patients

- PMLiVE

UCB bags FDA approval for epilepsy drug Briviact

Wins US licence as the add-on treatment is launched in Germany and the UK

- PMLiVE

The price is right?

To market new innovation against a backdrop of restricted budgets, companies must work hard - and start early

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