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- PMLiVE

vortioxetine

- PMLiVE

Brexit “having impact on EU drug development”

EMA and UK regulator both affected

- PMLiVE

Lundbeck snaps up Abide Therapeutics for $400m

Also acquires its lead drug for Tourette’s syndrome

- PMLiVE

Lilly to withdraw Lartruvo, a first for accelerated approval failures

Existing patients can use access programme

- PMLiVE

AVEO warns EU approval of Fotivda could be at risk

Concerns arose with overall survival data

- PMLiVE

Sage’s postpartum depression treatment Zulresso gains US approval

First approval of its kind

- PMLiVE

Depression drug failure adds to Allergan’s woes

Axe hangs over remaining monotherapy and suicidality trials

- PMLiVE

J&J’s Spravato breaks depression drought at FDA

The esketamine nasal spray is the first new-mechanism antidepressant to be licensed in decades

- 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

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