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- PMLiVE

Amgen gets priority review for chronic heart failure hope

Raises expectations for early entry onto US market for ivabradine

- PMLiVE

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

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

- PMLiVE

FDA gives green light to Genzyme’s oral Gaucher drug

Oral therapy Cerdelga is set to complement intravenous Cerezyme

- PMLiVE

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

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

- PMLiVE

Acura must provide FDA more info on pain drug

Regulator questions abuse-resistant ability of Aversion

- PMLiVE

Avastin gets US green light for late-stage cervical cancer

Fifth oncology indication for Roche’s medicine

- PMLiVE

Celltrion submits biosimilar Remicade for US approval

Drug is second to be assessed by FDA under biosimilars pathway

- PMLiVE

FDA approves Merck’s insomnia drug

Belsomra is first orexin receptor antagonist available in US

- PMLiVE

FDA approves J&J’s diabetes combo

Invokamet combines Invokana and metformin to help reduce blood sugar

- PMLiVE

FDA ‘must publish biosimilar naming guide soon’

US politicians push regulator to finalise guidance

- PMLiVE

J&J’s Imbruvica wins new cancer indication

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

- PMLiVE

FDA approves pain drug that has reduced risk of abuse

Purdue’s Targiniq ER developed to deter snorting and injection

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