Blog
RSS FeedPosted by Michael Wonder on 28 Mar 2024
IntraBio announces US FDA accepts new dug application for IB1001 for the treatment of Niemann-Pick disease type C
26 March 2024 - PDUFA date set for 24 September 2024. ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 29 Dec 2020
European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis
28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
Posted by Michael Wonder on 27 Feb 2019
Bayer completes rolling submission for darolutamide in U.S.
27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to ...
Posted by Michael Wonder on 13 Nov 2017
Sunovion announces FDA acceptance for review of new drug application for dasotraline for the treatment of ADHD
10 November 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 10 Nov 2017
FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in the treatment of ADPKD
9 November 2017 - Tolvaptan has been studied in patients with autosomal dominant polycystic kidney disease in a clinical trial program ...
Posted by Michael Wonder on 08 Nov 2017
Company statement on resubmission of biosimilar trastuzumab and pegfilgrastim dossiers with EMA
7 November 2017 - Biocon´s partner Mylan has resubmitted the marketing authorisation applications for our proposed biosimilar trastuzumab and pegfilgrastim with ...
Posted by Michael Wonder on 08 Nov 2017
GSK submits US regulatory application for mepolizumab in eosinophilic chronic obstructive pulmonary disease
7 November 2017 - GlaxoSmithKline today announced the submission of a supplemental biologics license application to the United States FDA, ...
Posted by Michael Wonder on 07 Nov 2017
Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency
6 November 2017 - The application for marketing approval is based on the COMPASS study. ...
Posted by Michael Wonder on 06 Nov 2017
Novartis reaches another regulatory milestone for CTL019 (tisagenlecleucel) with submission of its MAA to EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL
6 November 2017 - Submission of application includes data from global, multi-center Phase II ELIANA and JULIET studies, including 6-month JULIET ...
Posted by Michael Wonder on 05 Nov 2017
Trevena announces submission of new drug application to U.S. FDA for Olinvo (oliceridine injection)
2 November 2017 - Filing supported by positive Phase 3 APOLLO and ATHENA studies. ...
Posted by Michael Wonder on 26 Jun 2017
Shire announces EMA validation of Veyvondi [von Willebrand factor (recombinant)] marketing authorisation application for treatment of von Willebrand disease
22 June 2017 - Veyvondi is the first and only recombinant von Willebrand factor treatment for adults with von Willebrand disease, ...
Posted by Michael Wonder on 23 Jun 2017
Kamada announces withdrawal of European marketing authorisation application for inhaled alfa-1 anti-trypsin for treatment of alfa-1 anti-trypsin deficiency disease
22 June 2017 - Kamada today announced that the company has withdrawn the marketing authorisation application for its proprietary inhaled ...
Posted by Michael Wonder on 23 Jun 2017
pSivida submits marketing authorisation application for approval of Durasert three year treatment for posterior segment uveitis in the European Union
22 June 2017 - pSivida has submitted a Marketing Authorization Application to the EMA, seeking approval to market the Company's Durasert ...
Posted by Michael Wonder on 22 Jun 2017
Seattle Genetics submits supplemental biologics license application to FDA for Adcetris (brentuximab vedotin) in cutaneous T cell lymphoma
20 June 2017 - Application based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator sponsored ...