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- PMLiVE

Protelos

- PMLiVE

EMA starts review of Xtandi in non-metastatic prostate cancer

The evaluation is based on positive results from the PROSPER trial

- PMLiVE

EMA’s Amsterdam home will not be ready in time

Staff will initially move to a temporary building in the city after Brexit

- PMLiVE

EMA hands UniQure orphan status first in Huntington’s

The Dutch biotech expects to file the treatment for approval later this year

- PMLiVE

NICE backs trial of online and mobile depression programme

First digital psychological therapy briefing covers Servier and Gaia's Deprexis

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

AstraZeneca AZ

AZ speeds first-line lung cancer filing for Tagrisso to EMA

As FLAURA trial results show boosted progression-free survival

- PMLiVE

EMA forges closer ties with HTA umbrella group

Agrees joint work plan with the European Network for Health Technology Assessment

- PMLiVE

Amsterdam picked to host the European Medicines Agency

But regulator faces a “challenging” relocation project to depart from London

- PMLiVE

Merck pulls Keytruda filing in Europe, despite US approval

Phase II KeyNote-0241 trial results failed to win over the EMA

- PMLiVE

Moving times

Continuity and stability are vital when it comes to the EMA's relocation when it leaves London

- PMLiVE

EMA sets aside £32m for temporary staff to help with Brexit move

As agency warns current tender system needs to be updated

EU flag

Europe’s cancer drug regulation is ‘broken’, claims study

Suggests EMA oncology approvals could lead to wasted funds and patient harm

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