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US Congress

Novartis building

Novartis gets FDA green light for new Ilaris indication

Immunotherapeutic wins US approval for severe form of childhood arthritis

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FDA to review Merck & Co’s allergy immunotherapy

Accepts application for oral tablet to protect against ragweed-based allergies

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Merck & Co wins green light in US for Zetia-Lipitor combo

Vytorin extension wins FDA approval

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FDA committee turns down Aveo/Astellas’ cancer drug

Tivozanib unable to prove superiority to Bayer's Nexavar

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FDA says Janssen’s myeloma drug is a ‘breakthrough therapy’

Should speed up regulatory process for daratumumab

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GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

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FDA approves drugs for rare genetic liver condition and to reverse anticoagulation

Raptor’s Procysbi and CSL Behring’s Kcentra recommended in US

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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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