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- PMLiVE

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CHMP recommends new Keytruda dosing schedule

Will apply to eight indications across five tumour types

- 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

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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

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Novartis withdraws EU filing for canakinumab

Further setback for cardiovascular blockbuster potential

- PMLiVE

CHMP backs Sanofi’s all-oral sleeping sickness drug

Sanofi's drug and others given green light by EMA committee

- PMLiVE

Roche pulls EU Tecentriq/Avastin filing in kidney cancer

Another setback for Roche, but CHMP changes its mind on Opdivo/Yervoy

- 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

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