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Intellipharmaceutics

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Celltrion submits biosimilar Remicade for US approval

Drug is second to be assessed by FDA under biosimilars pathway

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FDA approves Merck’s insomnia drug

Belsomra is first orexin receptor antagonist available in US

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FDA approves J&J’s diabetes combo

Invokamet combines Invokana and metformin to help reduce blood sugar

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FDA ‘must publish biosimilar naming guide soon’

US politicians push regulator to finalise guidance

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J&J’s Imbruvica wins new cancer indication

FDA backs drug’s use in chronic lymphocytic leukaemia patients with genetic mutation

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FDA approves pain drug that has reduced risk of abuse

Purdue’s Targiniq ER developed to deter snorting and injection

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Neupogen will be first biologic on FDA biosimilars pathway

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

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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

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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

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Otsuka and Lundbeck file Abilify follow-up in the US

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

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