‘Regulatory science to 2025’: live broadcast of post-consultation workshop

11 November 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its ...

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Johnson & Johnson announces submission of European marketing authorisation applications for Janssen’s investigational Ebola vaccine regimen

7 November 2019 - Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated ...

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EMA validates Bratovi, Mektovi application for some mCRC

7 November 2019 - The EMA has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for ...

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Octapharma’s fibryga receives European label extension to treat acquired fibrinogen deficiency (AFD)

5 November 2019 - Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of ...

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Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis

31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...

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EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder

30 October 2019 - The applications will be reviewed under accelerated assessment by EMA. ...

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Dupixent (dupilumab) now approved in European Union for severe chronic rhinosinusitis with nasal polyposis

29 October 2019 - First biologic approved in the European Union for adults with severe chronic rhinosinusitis with nasal polyposis. ...

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Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe

29 October 2019 - GlaxoSmithKline today announced that the European Commission has adopted a decision to extend to children five years ...

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European Commission approves Bavencio (avelumab) plus axitinib combination for first-line treatment of patients with advanced renal cell carcinoma

28 October 2019 - EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with Bavencio ...

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European Commission approves Astellas’ Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation

25 October 2019 - Approval follows accelerated assessment, orphan designation by European Medicines Agency. ...

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Dialogue with Chinese authorities on medicine regulation

25 October 2019 - The Deputy Commissioner of the Chinese National Medical Product Administration, Dr Chen Shifei, visited EMA on ...

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Novartis receives approval for Cosentyx label update in Europe to include dosing flexibility in ankylosing spondylitis

24 October 2019 - New Cosentyx (secukinumab) label to include 300 mg up-titration option is informed by results from the Phase ...

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European Commission approves Opdivo (nivolumab) four week dosing schedule for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

24 October 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) flat dosing schedule of ...

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Janssen seeks to expand use of Tremfya (guselkumab) in the treatment of adults with active psoriatic arthritis

23 October 2019 - If approved, guselkumab will be the first selective IL-23 p19 subunit inhibitor for people in the European ...

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Enhancing consistency in wording of therapeutic indications to support health care decision-making

21 October 2019 - EMA’s human medicines committee has developed a paper to strengthen consistency when defining therapeutic indications in the ...

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