28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
7 November 2017 - Biocon´s partner Mylan has resubmitted the marketing authorisation applications for our proposed biosimilar trastuzumab and pegfilgrastim with ...
6 November 2017 - The application for marketing approval is based on the COMPASS study. ...
6 November 2017 - Submission of application includes data from global, multi-center Phase II ELIANA and JULIET studies, including 6-month JULIET ...
22 June 2017 - Veyvondi is the first and only recombinant von Willebrand factor treatment for adults with von Willebrand disease, ...
22 June 2017 - Kamada today announced that the company has withdrawn the marketing authorisation application for its proprietary inhaled ...
22 June 2017 - pSivida has submitted a Marketing Authorization Application to the EMA, seeking approval to market the Company's Durasert ...
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018. ...
14 June 2017 - Novo Nordisk today announced the submission of a type II variation application to the EMA for including ...
5 June 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA and a ...
1 June 2017 - Priority review voucher submitted in US with anticipated target action date of 6 months. ...
31 May 2017 - Applications seek to expand approved use of Sutent based on data from the Phase 3 S-TRAC trial. ...
31 May 2017 - These regulatory submissions follow soon after two positive CHMP opinions for Sandoz biosimilars etanercept and rituximab further ...
23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...
22 May 2017 - Fujifilm Kyowa Kirin Biologics announces that on May 18, 2017, the EMA has accepted for review the ...