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soft tissue sarcoma

- 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

Lilly ramps up social media use

Next phase of LillyPad blog expansion aims at journalists

- PMLiVE

FDA bars generic version of Purdue’s painkiller OxyContin

New abuse-deterrent formulation means original version no longer has positive benefit-to-risk profile

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