Celgene receives European Commission approvals for Revlimid (lenalidomide) and Imnovid (pomalidomide)-based triplet combination regimens for patients with multiple myeloma

16 May 2019 - The European Commission has approved two of Celgene’s IMiD based combination regimens. ...

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Will drugs companies follow EU agency from London to Amsterdam?

16 May 2019 - Amid the bustling skyscrapers of London’s Canary Wharf, one building stands silent and shuttered — a ...

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EMA begins search for next Executive Director

14 May 2019 - As Guido Rasi wraps up his second five-year term as the executive director of the European ...

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Nabriva Therapeutics announces submission of marketing authorisation application for lefamulin to treat community-acquired pneumonia in adults by European Medicines Agency

8 May 2019 - Nabriva Therapeutics announced that the Company’s marketing authorisation application for both the intravenous  and oral ...

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European Commission approves Lorviqua (lorlatinib) for certain adult patients with previously treated ALK positive advanced non-small cell lung cancer

7 May 2019 - Pfizer today announced that the European Commission granted conditional marketing authorisation for Lorviqua (lorlatinib, available in ...

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Dupixent (dupilumab) approved for severe asthma by European Commission

7 May 2019 - Only biologic approved in the European Union for severe asthma with type 2 inflammation, as characterised by ...

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Akcea and Ionis announce approval of Waylivra (volanesorsen) in the European Union

7 May 2019 - Akcea Therapeutics and Ionis Pharmaceuticals announced today that Waylivra has received conditional marketing authorisation from the ...

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Working together for safe medicines in the EU

6 May 2019 - EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines ...

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European Commission approves Palynziq (pegvaliase injection) for treatment of phenylketonuria in patients aged 16 years or older

6 May 2019 - First enzyme substitution therapy approved in Europe to treat the underlying cause of phenylketonuria in patients aged ...

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Two additional countries to benefit from EU-US mutual recognition agreement for inspections

30 April 2019 - In April 2019, the US FDA confirmed the capability of two additional European Union Member States ...

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European Commission approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis

30 April 2019 - Approval based on results from clinical studies showing high rates of skin clearance at 16 weeks; this ...

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Zynquista now approved in the European Union for treatment of adults with type 1 diabetes

27 April 2019 - The European Commission has granted marketing authorisation for Zynquista (sotagliflozin), developed by Sanofi and Lexicon.  ...

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Evolus receives positive CHMP opinion for Nuceiva in the European Union

26 April 2019 - European Commission approval anticipated within 90 days. ...

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Pfizer receives positive CHMP opinion for Talzenna (talazoparib) for patents with inherited (germline) BRCA mutated locally advanced or metastatic breast cancer

26 April 2019 - Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor ...

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Celgene Corporation and Acceleron Pharma announce submission of luspatercept marketing authorisation application to the EMA for MDS and beta-thalassemia

26 April 2019 - Submission to EMA follows biologics licensing application submission to U.S. FDA earlier this month. ...

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