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- PMLiVE

Dovato

- PMLiVE

EMA sees approval numbers rise in 2018

Agency faces Brexit test in 2019

- PMLiVE

Novartis withdraws EU filing for canakinumab

Further setback for cardiovascular blockbuster potential

- PMLiVE

CHMP delays decision on Kiadis’ GVHD immunotherapy

Medicines regulator issues out Day 180 List of Outstanding Issues

- PMLiVE

Stakeholder dialogue in Europe’s adaptive pathways pilot

Is enhanced dialogue with wide stakeholder groups crucial to being able to respond to an unmet medical need?

- PMLiVE

New chair for Europe’s key medicines committee

Appointment comes amid Brexit-induced disruption and new era in medicines

Sanofi reception

Sanofi gets EU OK for Ablynx flagship drug Cablivi

EMA clears the drug to treat adults with aTTP

The European Medicines Agency: PRIME’d for access?

Leela Barham examines the impact of the EMA's PRIME fast track system after two years

- PMLiVE

EMA cuts back as Brexit staff losses top expectations

Regulator says it faces loss of 30% of staff

- PMLiVE

Some pharma companies not prepared for Brexit, warns EMA

Regulator concerned about medicines shortages after March 2019

- PMLiVE

CAR-Ts Kymriah and Yescarta step closer to approval in Europe

Final European approval around the corner - but reimbursement and specialist centres among outstanding issues

Gilead Sciences

Gilead’s Biktarvy gets European approval, setting up battle with GSK

The drug could offset Gilead's disappointing hep C franchise

- PMLiVE

Daily Brief: Andrew Witty’s replacement on Accelerated Access initiative, Blincyto gains full EU approval and more

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