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- PMLiVE

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

Follows unanimous negative committee vote

- PMLiVE

FDA knocks back Durect’s painkiller

Regulator wants more safety information for Posidur

- PMLiVE

FDA clears J&J’s Imbruvica for leukaemia

Adds to cancer drug's lymphoma indication

- PMLiVE

FDA to review safety of AZ’s saxagliptin

Diabetes drug linked to heart failure

- PMLiVE

Teva faces US marketing investigation

Department of Justice to probe promotion tactics for Copaxone and Azilect

- PMLiVE

FDA deems GSK anaemia drug a ‘breakthrough’

US regulator will accelerate review of Promacta

- PMLiVE

FDA approves sleep disorder drug for blind people

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

- PMLiVE

CHMP turns down drugs for MS, cancer and muscular dystrophy

Negative EU recommendations for Teva, AB Science and PTC Therapeutics

- PMLiVE

FDA panel backs Merck’s vorapaxar

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

- PMLiVE

FDA panel backs Chelsea’s Northera for rare disease

Committee votes in favour of treatment for low blood pressure

- PMLiVE

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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