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RSS FeedPosted by Michael Wonder on 04 Apr 2019
EMA validates Daiichi Sankyo’s marketing authorisation application for pexidartinib for treatment of patients with TGCT, a rare, debilitating, non-malignant tumour
4 April 2019 - EU marketing authorisation application follows recent filing of the pexidartinib new drug application by the U.S. FDA ...
Posted by Michael Wonder on 02 Apr 2019
European Medicines Agency accepts Takeda’s marketing authorisation application for a subcutaneous formulation of vedolizumab for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s disease
1 April 2019 - Additional treatment modality would provide greater choice in how patients receive gut-selective biologic vedolizumab. ...
Posted by Michael Wonder on 02 Apr 2019
Heron announces European Medicines Agency validation of marketing authorisation application for HTX-011 for post-operative pain management
1 April 2019 - Heron Therapeutics today announced that the marketing authorisation application for its investigational agent, HTX-011, for post-operative pain, ...
Posted by Michael Wonder on 01 Apr 2019
Shionogi announces submission of cefiderocol marketing authorisation application
1 April 2019 - Shionogi announces that the marketing authorisation application submission for cefiderocol, a novel siderophore cephalosporin, has been accepted ...
Posted by Michael Wonder on 29 Mar 2019
Dynavax announces European Medicines Agency accepts marketing authorisation application for Heplisav-B for prevention of hepatitis B in adults
28 March 2019 - Dynavax Technologies today announced that the EMA has accepted the Company’s marketing authorisation application for review ...
Posted by Michael Wonder on 23 Mar 2019
Genmab announces European regulatory submission for daratumumab in combination with lenalidomide and dexamethasone in frontline multiple myeloma
22 March 2019 - Type II variation application submitted to the EMA for daratumumab in combination with lenalidomide and dexamethasone as ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...
Posted by Michael Wonder on 13 Mar 2019
Advicenne announces submission of European marketing authorisation application for ADV7103 as treatment for distal renal tubular acidosis
12 March 2019 - Advicenne announces today that it has submitted a marketing authorisation application to tEMA for its lead ...
Posted by Michael Wonder on 11 Mar 2019
Celgene submits application to EMA for ozanimod for the treatment of relapsing-remitting multiple sclerosis
11 March 2019 - New drug application submission to U.S. FDA on track for end of March. ...
Posted by Michael Wonder on 10 Mar 2019
Bayer submits European marketing authorisation application for darolutamide
8 March 2019 - Third submission for darolutamide in two weeks underscores Bayer's commitment to fill an unmet need for men ...
Posted by Michael Wonder on 08 Mar 2019
European Medicines Agency validates application for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
8 March 2019 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...
Posted by Michael Wonder on 04 Mar 2019
Novo Nordisk files for a label update for Fiasp to the EMA and the FDA seeking approval for use in children and adolescents
1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the EMA and the US FDA ...
Posted by Michael Wonder on 02 Mar 2019
Hansa Biopharma announces European Medicines Agency accepts marketing authorisation application for Idefirix (imlifidase)
1 March 2019 - Hansa Biopharma announced today that the EMA has accepted the company's marketing authorisation application for review of ...
Posted by Michael Wonder on 01 Mar 2019
Esperion announces submissions of two NDAs and official completion of two MAA validations for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet
28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including ...
Posted by Michael Wonder on 01 Mar 2019
Astellas announces acceptance of Xospata (gilteritinib) for regulatory review by the European Medicines Agency
28 February 2019 - Astellas Pharma announced today that the submission for a marketing authorisation application for the oral once-daily ...