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10 July 2015 | By Victoria White
Janssen-Cilag International announced today that the European Commission (EC) has approved Imbruvica® (ibrutinib) capsules as a treatment option for adult patients with Waldenström’s macroglobulinemia (WM).
27 May 2015 | By Victoria White
The CHMP has recommended approval of STELARA for the treatment of moderate to severe plaque psoriasis in adolescent patients aged 12 and older...
6 February 2015 | By Janssen EMEA
Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved a variation to the terms of the marketing authorisation of VELCADE® (bortezomib) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for blood…
10 December 2014 | By Janssen
Janssen-Cilag International NV (Janssen) is pleased to announce the presentation of new longer term follow-up data from two IMBRUVICA® (ibrutinib) studies at the American Society of Hematology (ASH) meeting in San Francisco, CA. IMBRUVICA is a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor.
1 December 2014 | By Janssen-Cilag International
Janssen-Cilag International NV (Janssen) announced today the submission of a Type II variation application to the European Medicines Agency (EMA) to vary the marketing authorisation for IMBRUVICA® (ibrutinib), to include a new therapeutic indication, the treatment of adult patients with Waldenström’s macroglobulinemia (WM). If approved, this latest regulatory submission will…
25 November 2014 | By Janssen
Janssen-Cilag International NV announced that the European Commission (EC) has approved the use of REZOLSTA® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older...
20 October 2014 | By Janssen
Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved IMBRUVICA™ (ibrutinib) capsules, a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor.
14 October 2014 | By Janssen
Persistence of STELARA® (ustekinumab) significantly better than anti-TNFs in treatment of psoriasis according to observational study analysis...
29 September 2014 | By Janssen
Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a Positive Opinion recommending REZOLSTA™...
19 May 2014 | By Janssen Pharmaceutical Companies
Janssen-Cilag International NV today announced that its next generation protease inhibitor OLYSIOTM (simeprevir) has been granted marketing authorisation by the European Commission for the treatment of adults with genotype 1 and 4 chronic hepatitis C...
30 October 2013 | By Johnson & Johnson
“The EMA Marketing Authorisation Application is an important milestone in the development of ibrutinib...”
15 October 2013 | By Johnson & Johnson
...for a fixed-dose combination tablet of HIV-1 medicine Darunavir with Cobicistat...
8 August 2013 | By Johnson & Johnson
Janssen announced that the European Commission has approved the use of VELCADE® (bortezomib)...
24 April 2013 | By Burson-Marsteller
Janssen has submitted a MAA to the EMA seeking approval for simeprevir...
11 January 2013 | By Johnson & Johnson
Janssen announced that the EC has approved an extension to the license of the oral, once-daily medication ZYTIGA®...
