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Gaucher disease

- PMLiVE

FDA committee turns down Aveo/Astellas’ cancer drug

Tivozanib unable to prove superiority to Bayer's Nexavar

- PMLiVE

FDA says Janssen’s myeloma drug is a ‘breakthrough therapy’

Should speed up regulatory process for daratumumab

- PMLiVE

GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

- PMLiVE

Court blocks EMA release of pharma company data

AbbVie and InterMune successfully challenge request for trial data for Humira and Esbriet

- PMLiVE

FDA approves drugs for rare genetic liver condition and to reverse anticoagulation

Raptor’s Procysbi and CSL Behring’s Kcentra recommended in US

- PMLiVE

FDA refuses to back Gilead’s two HIV drugs

Agency questions quality of testing procedures for elvitegravir and cobicistat

- PMLiVE

Lilly expects to submit five drugs for US approval in 2013

Hopes FDA submissions will help offset patent losses for Zyprexa and Cymbalta

- PMLiVE

Two new cancer drugs recommended in Europe

CHMP backing for Roche's Erivedge and Astellas' Xtandi

- PMLiVE

EMA refuses to back Pfizer’s Xeljanz in rheumatoid arthritis

Surprise after approvals in US and Japan

- PMLiVE

European drug applications ‘stable but more complex in 2012’

Despite austerity measures, EMA's annual report shows signs of biopharma resilience

- PMLiVE

FDA stung by damning fraudulent research report

Agency accused of leaving untested drugs on the market

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