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- PMLiVE

FDA approves pain drug that has reduced risk of abuse

Purdue’s Targiniq ER developed to deter snorting and injection

- PMLiVE

Neupogen will be first biologic on FDA biosimilars pathway

US regulator will review Novartis’  version of Amgen's Neupogen (filgrastim) over the coming months

- PMLiVE

FDA approves Gilead drug in three blood cancers

Zydelig recommended for use in chronic lymphocytic leukaemia and two forms of lymphoma

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BMJ accuses Boehringer of withholding Pradaxa data

Claims current FDA recommendation for anticoagulant may be flawed

- PMLiVE

FDA approves drug for rare swelling diseases

Salix and Pharming’s Ruconest is made from the milk of genetically-modified rabbits

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Priority review for Roche’s Avastin in cervical cancer

Will speed up FDA assessment of oncology drug

- PMLiVE

Otsuka and Lundbeck file Abilify follow-up in the US

Brexpiprazole to be reviewed for use in schizophrenia and major depressive disorder

- PMLiVE

Sun Pharma recalls antidepressant in US

Withdraws more than 40,000 bottles of venlafaxine hydrochloride

dengue fever mosquito

Sanofi’s dengue vaccine could debut in 2015

End in sight after 20-year wait for first effective vaccine

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EMA transparency policy delayed over ‘wording’

Regulation on access to trial data postponed until October

- PMLiVE

FDA sets out framework for rare childhood diseases

Wants to encourage more trial use of biomarkers and speedier approval timelines

- PMLiVE

FDA to review Sanofi’s Lantus successor

Decision on company’s next generation insulin Toujeo expected early next year

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