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- PMLiVE

Second approval in US for Bayer-Onyx’ Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

- 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

Search appears on FDA’s radar once again

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

- PMLiVE

Gilead settles patent dispute with Teva over Viread generic

Launch of generic HIV drug held back until December 2017

- 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

Teva facing $2bn liability for at-risk generic Protonix launch

Potential litigation costs from Pfizer are triple the generics firm's original estimates

- PMLiVE

Global counterfeit drug business driven by crime and corruption

Institute of Medicines says international cooperation needed to tackle falsified medicines

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