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- PMLiVE

Janet Woodcock

FDA smartphone regulation could stifle innovation

US House Republicans issue warning on guidance and call for more information

- PMLiVE

Second approval in US for Bayer-Onyx’ Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

Roche - Basel

Roche’s Herceptin follow-up cleared in US

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

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

- PMLiVE

Celgene gets US green light for blockbuster candidate Pomalyst

FDA approval to treat multiple myeloma

- PMLiVE

FDA proffers guidance for new Alzheimer’s drugs

Encourages approach that tackles disease in its early stages

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