Blog
RSS FeedPosted by Michael Wonder on 09 Mar 2018
Melinta Therapeutics partner, Menarini Group, submits marketing authorisation application for delafloxacin in Europe
8 March 2018 - Melinta Therapeutics today announced that The Menarini Group, Melinta’s commercial and co-development partner, has submitted a ...
Posted by Michael Wonder on 05 Mar 2018
The EMA accepts regulatory submission for Forxiga in adults with type-1 diabetes
5 March 2018 - First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes. ...
Posted by Michael Wonder on 04 Mar 2018
EMA started the evaluation of resubmitted marketing authorisation application for biosimilar pegfilgrastim
2 March 2018 - STADA Arzneimittel was informed today by Gedeon Richter that the EMA has accepted the regulatory resubmission ...
Posted by Michael Wonder on 28 Feb 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
Posted by Michael Wonder on 27 Feb 2018
Shionogi announces FDA new drug application and EMA marketing authorisation application acceptances for lusutrombopag (S-888711)
26 February 2018 - Shionogi announced today that the new drug application for lusutrombopag (S-888711), an investigational, once-daily, orally administered, ...
Posted by Michael Wonder on 15 Feb 2018
GSK submits landmark IMPACT data to European Medicines Agency to support expanded label for Trelegy Ellipta
14 February 2018 - GlaxoSmithKline and Innoviva today announced the submission of the landmark IMPACT data to the European Medicines ...
Posted by Michael Wonder on 14 Feb 2018
Advaxis submits conditional marketing authorisation application for axalimogene filolisbac for the second-line treatment of metastatic cervical cancer in European Union
13 February 2018 - The submission is centred around the encouraging results from the GOG-0265 study. ...
Posted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 10 Feb 2018
Janssen submits marketing authorisation application for apalutamide to treat patients with high-risk non-metastatic castration-resistant prostate cancer
9 February 2018 - Phase 3 SPARTAN data showed apalutamide improved median metastasis-free survival by over two years compared to placebo. ...
Posted by Michael Wonder on 06 Feb 2018
GW Pharmaceuticals announces the EMA accepts Epidiolex (cannabidiol) marketing authorisation application for review
5 February 2018 - Application seeking regulatory approval of Epidiolex for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. ...
Posted by Michael Wonder on 03 Feb 2018
European Medicines Agency accepts fremanezumab marketing authorisation application
2 February 2018 - Teva seeking EU regulatory approval for anti-CGRP therapy for the prevention of migraine. ...
Posted by Michael Wonder on 01 Feb 2018
Sanofi, DNDi seek European Medicines Agency review for sleeping sickness treatment
1 February 2018 - Dossier will be reviewed under the Article 58 procedure, which is intended for medicines that will be ...
Posted by Michael Wonder on 26 Jan 2018
Alnylam Announces EMA acceptance of marketing authorisation application for patisiran for the treatment of hereditary ATTR amyloidosis
25 January 2018 - EMA will evaluate the application under accelerated assessment. ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 08 Jan 2018
European Medicines Agency accepts filing for Evenity (romosozumab)
8 January 2018 - Application supported by Phase 3 data in more than 11,000 post-menopausal women and men with osteoporosis at ...