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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

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Genital herpes vaccine candidate promising in phase II

Genocea Biosciences’ GEN-003 found to reduce recurrence and transmission of the virus

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

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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

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FDA rejects PTC’s application for muscular dystrophy drug

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

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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

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UCB bags FDA approval for epilepsy drug Briviact

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

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Roche and AZ claim FDA breakthrough status for new drugs

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

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Forging a path in specialty care

Takeda’s Marc Princen on the company’s plans to build a reputation in oncology, gastroenterology and vaccine

dengue fever mosquito

EMA creates Zika virus task force

Will aid research and development of vaccines and medicines

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