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- PMLiVE

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Drug regulators collaborate to tackle Ebola outbreak

EMA and FDA team up with global partners to accelerate access to medicines

- PMLiVE

Amgen submits melanoma and cholesterol drugs to EMA

Regulator will assess talimogene laherparepvec and evolocumab

- PMLiVE

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

Two blood cancer drugs among CHMP recommendations

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

Genentech’s Sunil Agarwal joins rare disease firm

He will serve as chief medical officer at Ultragenyx

EU flag

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

The moving parts of orphan drug development

Tackling rare diseases requires high levels of cooperation, regulatory support and a determination to succeed

- 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

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