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- PMLiVE

Sivextro

- 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

- 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

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

Alnylam’s amyloidosis drug heads latest crop of CHMP approvals

Three new biosimilars also gets the green light

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