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FDA refuses to back Gilead’s two HIV drugs

Agency questions quality of testing procedures for elvitegravir and cobicistat

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Lilly expects to submit five drugs for US approval in 2013

Hopes FDA submissions will help offset patent losses for Zyprexa and Cymbalta

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FDA stung by damning fraudulent research report

Agency accused of leaving untested drugs on the market

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FDA bars generic version of Purdue’s painkiller OxyContin

New abuse-deterrent formulation means original version no longer has positive benefit-to-risk profile

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FDA approves return of morning sickness drug for pregnant women

Regulator confirms safety of Diclegis – formerly known as Bendectin

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Bayer’s riociguat fast-tracked by FDA

Could provide oral option in pulmonary arterial hypertension market

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EMA launches diabetes drugs safety review

Will investigate pancreatitis risks in two major drug classes

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FDA delays GlaxoSmithKline’s pandemic flu vaccine

More time needed due to "administrative" issue

FDA says final mobile app guidance just weeks away

And tells Congress only a fraction of mobile apps will need regulating

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Takeda suspended as vice president of Japanese industry body

Mis-labelling also prompts JPMA to takes action against CMO Nihon Pharmaceutical

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Black triangle monitoring warning to be used across EU

Use of symbol is part of EMA plans to strengthen pharmacovigilance

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Incyte says Jakafi patient developed brain virus

Investigation to determine if myelofibrosis drug is linked to PML

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