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- PMLiVE

ICMRA

- PMLiVE

EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

Roche - Basel

Roche’s Herceptin follow-up cleared in US

FDA approval for Kadcyla (formerly T-DM1) in breast cancer

- PMLiVE

CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

- PMLiVE

Gentium expects EMA rejection for defibrotide

Negative feedback for drug’s use in liver condition associated with stem cell transplantation

- PMLiVE

WHO says people now expect universal health coverage

But director general says nations need to take own path to achieve this goal

Search appears on FDA’s radar once again

Warning letter to Florida company puts new slant on regulator's digital focus

- PMLiVE

GSK’s COPD drug Anoro under review in US

FDA accepts new drug application for the LAMA/LABA combination

Sanofi reception

FDA to review Sanofi’s lixisenatide for diabetes

Follows drug's European approval under brand name Lyxumia earlier this month

- PMLiVE

Global counterfeit drug business driven by crime and corruption

Institute of Medicines says international cooperation needed to tackle falsified medicines

- PMLiVE

Genzyme’s Richard Moscicki joins FDA

Provides regulatory agency with more than 20 years of industry experience

- PMLiVE

FDA fast-tracks Bayer’s prostate cancer radiotherapy

Priority review for radium-223 dichloride, formerly called Alpharadin

- PMLiVE

Bayer submits oral PAH drug riociguat for approval

Set to challenge Actelion and Gilead

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