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FDA approves BMS/Pfizer’s Eliquis in DVT and PE

New blood clot indication puts drug on a level with rival oral anticoagulants

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FDA gives green light to Genzyme’s oral Gaucher drug

Oral therapy Cerdelga is set to complement intravenous Cerezyme

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‘Tentative’ US approval for Lilly/Boehringer’s Lantus copy

Full FDA recommendation for insulin is dependent on lawsuit filed by Sanofi

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Acura must provide FDA more info on pain drug

Regulator questions abuse-resistant ability of Aversion

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Avastin gets US green light for late-stage cervical cancer

Fifth oncology indication for Roche’s medicine

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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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