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- PMLiVE

Akynzeo

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GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

- PMLiVE

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

- PMLiVE

Eisai appoints Lynn Kramer chief clinical officer

Says newly created position will strengthen its research base

- PMLiVE

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

- PMLiVE

Pharma companies partner with Japanese government

GHIT Fund will support development of medicines for infectious diseases in developing countries

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Eisai expands into Russia with Halaven launch

Breast cancer drug will be followed by epilepsy portfolio

- PMLiVE

FDA delays GlaxoSmithKline’s pandemic flu vaccine

More time needed due to "administrative" issue

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