Blog
RSS FeedPosted by Michael Wonder on 30 Aug 2018
Theratechnologies files marketing authorisation application for Trogarzo in Europe
28 August 2018 - Theratechnologies is pleased to announce that the application for marketing authorization of Trogarzo (ibalizumab) was filed ...
Posted by Michael Wonder on 28 Aug 2018
Loxo Oncology announces submission of European marketing authorisation application for larotrectinib
27 August 2018 - Loxo Oncology today announced that its collaboration partner, Bayer, has submitted a marketing authorisation application for larotrectinib ...
Posted by Michael Wonder on 23 Aug 2018
Novimmune submits marketing authorisation application in Europe for its lead drug emapalumab
22 August 2018 - Novimmune today announced that it has successfully submitted a marketing authorisation application to the EMA seeking marketing ...
Posted by Michael Wonder on 09 Aug 2018
Genmab announces submission of U.S. & EU regulatory applications seeking approval of Darzalex (daratumumab) split dosing regimen
8 August 2018 - Applications seek to update prescribing information and summary of product characteristics. ...
Posted by Michael Wonder on 12 Jul 2018
Advaxis provides update on MAA filing
10 July 2018 - Advaxis today announced a clinical update. ...
Posted by Michael Wonder on 05 Jul 2018
Clovis Oncology receives EMA validation for its application for a new indication for Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer
5 July 2018 - The filing is based on positive phase 3 ARIEL3 clinical trial data in which rucaparib significantly improved ...
Posted by Michael Wonder on 28 Jun 2018
Alexion submits application for approval of ALXN1210 as a treatment for patients with paroxysmal nocturnal haemoglobinuria in the European Union
28 June 2018 - EU filing follows U.S. filing in June 2018. ...
Posted by Michael Wonder on 26 Jun 2018
La Jolla Pharmaceutical Company announces European Medicines Agency validation of marketing authorisation application for Giapreza (angiotensin II)
25 June 2018 - La Jolla Pharmaceutical Company today announced that the marketing authorisation application for Giapreza (angiotensin II) injection ...
Posted by Michael Wonder on 07 Jun 2018
U.S. FDA and EMA accept regulatory submissions for review of tazaloparib for metastatic breast cancer patients with an inherited BRCA mutation
7 June 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 05 Jun 2018
Mabion completes marketing authorisation application for flagship drug, MabionCD20, to the EMA
5 June 2018 - • Mabion is first Polish biotech company to successfully complete development of a biosimilar drug independently and to ...
Posted by Michael Wonder on 05 Jun 2018
Lupin submits marketing authorisation application for etanercept biosimilar in Europe
23 May 2018 - Pharma major Lupin announced today that its marketing authorization application for a biosimilar of etanercept has been ...
Posted by Michael Wonder on 04 Jun 2018
Clovis Oncology submits application to EMA to expand use of Rubraca (rucaparib) to include maintenance treatment for women with recurrent ovarian cancer
4 June 2018 - Submission based on positive phase 3 ARIEL3 clinical trial in which rucaparib significantly improved PFS in all ...
Posted by Michael Wonder on 29 May 2018
Acorda announces EMA validation of the MAA submission for Inbrija (levodopa inhalation powder)
29 May 2018 - Acorda Therapeutics today announced that the EMA has completed formal validation of Acorda’s marketing authorisation application ...
Posted by Michael Wonder on 29 May 2018
AB Science provides update on EU marketing authorisation application for masitinib in the treatment of amyotrophic lateral sclerosis
28 May 2018 - AB Science announces its decision not to pursue the re- examination procedure that the company initially ...
Posted by Michael Wonder on 03 May 2018
EMA validates Bristol-Myers Squibb’s type II variation application for Opdivo plus Yervoy combination for treatment of first-line metastatic non-small-cell lung cancer
3 May 2018 - If approved, Opdivo plus Yervoy would be the first I-O/I-O combination in the EU for first-line metastatic ...