Blog
RSS FeedPosted by Michael Wonder on 11 Nov 2019
‘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 ...
Posted by Michael Wonder on 09 Nov 2019
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 ...
Posted by Michael Wonder on 07 Nov 2019
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 ...
Posted by Michael Wonder on 06 Nov 2019
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 ...
Posted by Michael Wonder on 01 Nov 2019
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 ...
Posted by Michael Wonder on 30 Oct 2019
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. ...
Posted by Michael Wonder on 30 Oct 2019
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. ...
Posted by Michael Wonder on 30 Oct 2019
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 ...
Posted by Michael Wonder on 28 Oct 2019
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 ...
Posted by Michael Wonder on 26 Oct 2019
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. ...
Posted by Michael Wonder on 26 Oct 2019
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 ...
Posted by Michael Wonder on 24 Oct 2019
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 ...
Posted by Michael Wonder on 24 Oct 2019
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 ...
Posted by Michael Wonder on 23 Oct 2019
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 ...
Posted by Michael Wonder on 21 Oct 2019
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 ...