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Orencia

- PMLiVE

FDA to review Merck & Co’s allergy immunotherapy

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

- PMLiVE

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

Vytorin extension wins FDA approval

- PMLiVE

FDA committee turns down Aveo/Astellas’ cancer drug

Tivozanib unable to prove superiority to Bayer's Nexavar

- PMLiVE

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

Should speed up regulatory process for daratumumab

- PMLiVE

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

- PMLiVE

FDA refuses to back Gilead’s two HIV drugs

Agency questions quality of testing procedures for elvitegravir and cobicistat

- PMLiVE

Lilly expects to submit five drugs for US approval in 2013

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

- PMLiVE

BMS wins wider NICE Orencia arthritis approval

But only after cutting the drug's price

- PMLiVE

FDA stung by damning fraudulent research report

Agency accused of leaving untested drugs on the market

- PMLiVE

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

BMS plans major expansion of Orencia plant

Will invest $250m in biologics manufacturing facility

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