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US approval for Astellas’ new antifungal drug Cresemba

Japanese firm co-markets the azole antifungal agent with Basilea

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FDA approves first biosimilar

Novartis’ Sandoz unit gains new licence for Neupogen copycat

FDA launches drug shortages mobile app

USregulator offers the public and HCPs Android and iPhone versions of the app

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Novo Nordisk’s oral GLP-1 analogue looks set for phase III

Semaglutide said to be one of the firm’s most promising prospects

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Apotex latest to file Neupogen biosimilar in the US

White blood cell stimulator could be on the market this year

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FDA outlines its plans to simplify DTC ads for consumers

Hopes customer-friendly terminology will aid healthcare decisions

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Novo Nordisk confirms public listing for IT unit

Will spin off its NNIT business as a separate company

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Hamburg to resign as FDA commissioner

She has held the role for nearly six years

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Merck’s hep C drug no longer a ‘breakthrough’

FDA rescinds designation for grazoprevir/elbasvir due to approval of other treatments

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FDA approves first continuous glucose monitoring app

Clears remote blood sugar monitor Dexcom Share

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Pfizer’s Ibrance wins early breast cancer approval in US

FDA’s decision come two months ahead of schedule

Roche - Basel

Roche’s PD-1 wins second FDA ‘breakthrough’ status

Will accelerate review of MPDL3280A in lung cancer

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