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- PMLiVE

Clinical reports

- PMLiVE

AVEO warns EU approval of Fotivda could be at risk

Concerns arose with overall survival data

- PMLiVE

EMA could follow FDA’s Xeljanz blood clot warning

European agency in step with FDA after safety doubts

- PMLiVE

Big opportunities in big data, but EMA and industry just getting started

250m genomes sequenced, but data trapped in silos

- PMLiVE

European Medicines Agency departs London ahead of Brexit

Regulator moving to Amsterdam, as Novartis adds voice to no-deal warnings

- PMLiVE

EMA says Lilly’s Lartruvo should not be prescribed

First time EMA has acted on accelerated approval follow-up

- 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

Innovation in merger control and the impact on the pharmaceutical sector

Is focusing on pipeline products enough to assess regulatory risks?

- 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

GSK to reverse ‘no KOLs’ policy, admitting it has hit marketing

Company seeking to revive lacklustre marketing performance

- PMLiVE

New chair for Europe’s key medicines committee

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

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