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- PMLiVE

Gaucher disease

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

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

Genzyme on track for eliglustat filing in 2013

Says oral Gaucher disease drug as effective as its injectable Cerezyme

- 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

- PMLiVE

Celgene gets US green light for blockbuster candidate Pomalyst

FDA approval to treat multiple myeloma

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