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- PMLiVE

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

- PMLiVE

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

- PMLiVE

EU hits Servier and generic firms with €428m ‘pay-for-delay’ fine

Follows deals to delay competition for blood pressure drug Coversyl/Aceon

- 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

- PMLiVE

Japan first to approve Roche’s lung cancer drug alectinib

Personalised medicine has same target as Pfizer’s Xalkori and Novartis’ Zykadia

Novartis building

Novartis charged in Japan over data falsification

Prosecutors claim pharma company employees manipulated Diovan data

- PMLiVE

Amgen and Boehringer drugs win FDA breakthrough status

Leukaemia drug and Pradaxa antidote will benefit from accelerated regulatory processes

- PMLiVE

Third time lucky as MannKind’s inhaled insulin is approved

US FDA backs new diabetes treatment Afrezza

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