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- PMLiVE

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Europe’s cancer drug regulation is ‘broken’, claims study

Suggests EMA oncology approvals could lead to wasted funds and patient harm

- PMLiVE

EMA faces ‘permanent damage’ if forced to go to an unpopular city

Warns eight candidate cities wouldn't retain minimum staff numbers it needs

- PMLiVE

Takeda can’t sway NICE on oral myeloma therapy Ninlaro

Drug not recommended for NHS use in England and Wales

UK Life Sciences Strategy - one year on

EMA starts firming up its stance on personalised medicines

But draft guidelines won't be ready much before 2019

- PMLiVE

How to keep your name development on schedule after the recent EMA NRG announcement

Three key action points

- PMLiVE

Most of the EU would like to host the EMA

Nineteen member states will compete to host the agency when it leaves the UK

- PMLiVE

CHMP backs three immuno-oncology drugs for solid tumours

Roche, MSD and Merck/Pfizer are all on course for new European approvals later this year

- PMLiVE

Sanofi and Regeneron win CHMP nod for Dupixent

Atopic dermatitis treatment backed for European approval

- PMLiVE

Amgen aspires to new Kyprolis label in the US and Europe

Appeals to regulators to add survival data to multiple myeloma drug's labelling

- PMLiVE

Europe vs the US: New drug product approvals

As US approvals rates in the US drop,  the EU is not currently showing a similar trend

- PMLiVE

UK signals desire for close post-Brexit relationship with EU

Health and business ministers outline areas where collaboration may continue

- PMLiVE

EMA and FDA calls for innovative approaches for Gaucher disease medicines

The regulatory agencies also urge a similar method for all paediatric diseases

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