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- PMLiVE

Mysimba

- 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

- PMLiVE

Novo Nordisk and Evotec inks drug development deal

Will develop drugs for obesity and diabetes

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

- 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

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