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FDA backs BioMarin drug for rare enzyme disorder

Vimizim is first drug approved in US under rare paediatric disease priority review

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FDA knocks back J&J and Bayer’s Xarelto in ACS

Follows unanimous negative committee vote

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FDA knocks back Durect’s painkiller

Regulator wants more safety information for Posidur

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FDA clears J&J’s Imbruvica for leukaemia

Adds to cancer drug's lymphoma indication

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FDA to review safety of AZ’s saxagliptin

Diabetes drug linked to heart failure

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FDA deems GSK anaemia drug a ‘breakthrough’

US regulator will accelerate review of Promacta

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FDA approves sleep disorder drug for blind people

Vanda Pharmaceuticals wins backing for Hetlioz to improve a person’s body clock

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FDA panel backs Merck’s vorapaxar

On course for US approval to reduce vascular events in certain patients

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FDA panel backs Chelsea’s Northera for rare disease

Committee votes in favour of treatment for low blood pressure

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Another Ranbaxy plant falls foul of FDA

Indian company violates Good Manufacturing Practice

FDA releases draft social media guidance

Covers 'interactive promotional media', such as Facebook, Twitter and blogs

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Merck shares jump on melanoma drug filing

MK-3475 could be approved by end of 2014

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