Blog
RSS FeedPosted by Michael Wonder on 01 May 2018
AbbVie submits marketing authorisation application to the EMA for investigational treatment risankizumab for moderate to severe plaque psoriasis
1 May 2018 - Application supported by four pivotal Phase 3 trials evaluating more than 2,000 patients with moderate to severe ...
Posted by Michael Wonder on 23 Apr 2018
EMA validates Type II variation for Merck’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy as first-line therapy in metastatic non-squamous NSCLC, based on Phase 3 KEYNOTE-189 trial
23 April 2018 - Merck today announced that following validation by the EMA, the centralised review process has begun for the ...
Posted by Michael Wonder on 05 Apr 2018
Aradigm announces the EMA has completed its validation of the MAA submission
5 April 2018 - Aradigm Corporation today announced the completed formal validation by the EMA of the marketing authorisation application ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
Posted by Michael Wonder on 03 Apr 2018
EMA accepts regulatory submission for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer
3 April 2018 - If approved, AstraZeneca and MSD’s Lynparza would be the first PARP inhibitor to treat patients with breast ...
Posted by Michael Wonder on 03 Apr 2018
EMA to review cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
3 April 2018 - The EMA has accepted for review the marketing authorisation application for cemiplimab for the treatment of ...
Posted by Michael Wonder on 03 Apr 2018
EMA to review Dupixent (dupilumab) as potential treatment for inadequately controlled moderate-to-severe asthma
3 April 2018 - The EMA has accepted for review an application for Dupixent (dupilumab) as an add-on maintenance treatment ...
Posted by Michael Wonder on 29 Mar 2018
EMA to review sotagliflozin as potential treatment for type 1 diabetes
29 March 2018 - The EMA has accepted for review Sanofi’s regulatory submission for sotagliflozin. If approved, the oral treatment would ...
Posted by Michael Wonder on 29 Mar 2018
Shire reports regulatory milestones for investigational hereditary angioedema treatment lanadelumab
29 March 2018 - Filings are supported by data from HELP, the pivotal Phase 3 efficacy and safety study. ...
Posted by Michael Wonder on 29 Mar 2018
EMA accepts BioMarin's marketing application for pegvaliase MAA for treatment of phenylketonuria
28 March 2018 - BioMarin Pharmaceutical announced today that the EMA has accepted BioMarin's submission of a marketing authorisation application for ...
Posted by Michael Wonder on 28 Mar 2018
Ipsen announces EMA validation of filing of a new application for additional indication for Cabometyx
28 March 2018 - Ipsen today announced that the EMA has validated the filing of a new application for an ...
Posted by Michael Wonder on 27 Mar 2018
Lexicon Pharmaceuticals announces regulatory submissions for sotagliflozin to treat adults with type 1 diabetes
26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA. ...
Posted by Michael Wonder on 27 Mar 2018
Acorda files marketing authorisation application for Inbrija (levodopa inhalation powder)
26 March 2018 - Acorda Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 13 Mar 2018
Emmaus Life Sciences receives validation from EMA on marketing authorisation application for sickle cell disease treatment Xyndari (oral glutamine)
12 March 2018 - Emmaus Life Sciences announced today that the company’s marketing authorisation application for Xyndari has been fully ...
Posted by Michael Wonder on 11 Mar 2018
Aradigm submits marketing authorisation application to EMA for EU marketing approval of Linhaliq in non-cystic fibrosis bronchiectasis
9 March 2018 - Aradigm Corporation today announced it has submitted its marketing authorisation application to EMA for Linhaliq for ...