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- PMLiVE

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- 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

European drug applications ‘stable but more complex in 2012’

Despite austerity measures, EMA's annual report shows signs of biopharma resilience

- 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

Rare disease patients face 5-7 year wait for diagnosis

Doctors often lack time and resources to manage patients

- PMLiVE

FDA approves return of morning sickness drug for pregnant women

Regulator confirms safety of Diclegis – formerly known as Bendectin

Roche - Basel

Roche and Isis in $392m deal to research drugs for brain disorder

Will develop antisense drugs for Huntington's disease

Bayer symbol

Bayer’s riociguat fast-tracked by FDA

Could provide oral option in pulmonary arterial hypertension market

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