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- PMLiVE

Dovato

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EMA names head of comms team

Marie-Agnes Heine joins regulator from World Health Organization

- PMLiVE

EMA accepts Cubist antibiotic for review

Follows FDA priority review for ceftolozane/ tazobactam

- PMLiVE

ViiV bags US approval for HIV blockbuster-in-waiting

Drug combines antiretrovirals with Tivicay

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Two blood cancer drugs among CHMP recommendations

Five new drugs, including Janssen’s Imbruvica and Gilead’s Zydelig, backed for use in Europe

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EMA transparency policy delayed over ‘wording’

Regulation on access to trial data postponed until October

- PMLiVE

GSK wins approval for skin cancer drug Mekinist in EU

Will compete with Roche’s Zelboraf and BMS’ Yervoy in melanoma

- PMLiVE

Merck could win anti-PD1 therapy race in Europe

EMA accepts filing for promising pembrolizumab in melanoma

Novartis building

Novartis pulls EMA application for expanded Tasigna use

And Boehringer confirms it won't seek approval for faldaprevir as it exits hepatitis C

- PMLiVE

Biosimilar Lantus leads CHMP opinions

Boehringer and Lilly’s insulin one of six new medicines recommended for EU approval

- PMLiVE

Avastin first biologic backed in EU for resistant ovarian cancer

Roche drug recommended in latest round of CHMP opinions

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Updated EMA reports better suited to HTA needs

Changes to drug licensing reports are helping to support reimbursement decisions

- PMLiVE

EMA gives December deadline for information updates

Pharma companies must revise their medicines information by year-end

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