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- PMLiVE

tolvaptan

- PMLiVE

FDA allows accelerated review for rivals to over-priced drugs

Aims to combat growing trend in exploitation of sole-source drug pricing

- PMLiVE

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

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

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

UCB bags FDA approval for epilepsy drug Briviact

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

- PMLiVE

Roche and AZ claim FDA breakthrough status for new drugs

Designation could speed up development for Roche’s ocrelizumab and AZ’s durvalumab 

- PMLiVE

Merck & Co’s oral hepatitis C therapy approved in US

Fixed-dose combination Zepatier wins a licence from the FDA

- PMLiVE

FDA verdict on Amgen’s Humira biosimilar due in September

Begins review the version of AbbVie's big-selling anti-inflammatory drug

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