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Janet Woodcock

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Vertex submits Kalydeco combo for cystic fibrosis

Seeks approval in both US and Europe

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Guidance is no barrier to engaging on Twitter

Five simple, compliant tactics for European pharma marketers to consider

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US investigates Novo Nordisk manufacturing issues

Issues subpoena related to insulin plant in Kalundborg, Denmark

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FDA approves Baxter drug for rare form of haemophilia

Obizur is derived from pig proteins

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FDA votes to keep severe warning on Pfizer’s Chantix

Will not relax anti-smoking drug's side effect warning

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Boehringer’s Ofev approved by FDA for rare lung disease

US regulator also gives the green light to Intermune's Esbriet

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Pfizer’s palbociclib on track for early 2015 launch

Good news for the highly anticipated breast cancer drug

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Eisai wins US approval for chemotherapy side effects drug

FDA backs Akynzeo to treat nausea and vomiting

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Amgen leukaemia drug gets FDA priority review

Adds to breakthrough status for blinatumomab

Bristol Myers Squibb logo

BMS drops US application for ‘breakthrough’ hep C combination

Blames the 'rapidly evolving' market for asunaprevir withdrawal

Medical device firms told to address cybersecurity risks

FDA says online security should be part of a device's design and development

- PMLiVE

FDA awards $19m in rare disease grants

US regulator supports 15 orphan drug projects

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