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- PMLiVE

Qsiva

- PMLiVE

GSK/ Valeant’s Trobalt set for EU restrictions

Eye concerns prompt CHMP to recommend last-line use for the epilepsy drug

- PMLiVE

Novo Nordisk on track to file liraglutide in obesity

Expects regulatory filings in the US and EU by the beginning of 2014

- PMLiVE

France ignores EMA and suspends Bayer’s Diane 35

National Agency for the Safety of Drugs and Health Products contradicts PRAC verdict

Bayer symbol

EMA says Bayer’s Diane 35 should remain on European market

Agency investigation concludes acne treatment's benefits outweigh its risks

- PMLiVE

Belviq cleared for US launch after abuse risk determined

Drug Enforcement Administration says Arena's weight loss drug has relatively low risk of abuse

- PMLiVE

Arena pulls obesity drug Belviq application in EU

EMA asks for more data

- 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

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

EMA recommends heart risk restriction for Servier’s Protelos

Use of osteoporosis drug likely to be further tightened up

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