Blog
RSS FeedPosted by Michael Wonder on 01 May 2018
A comparative review of marketing authorisation decisions in Switzerland, the EU, and the USA
19 April 2018 - In this study we compared Swissmedic’s regulatory marketing authorisation decisions to those of the US FDA ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
Posted by Michael Wonder on 26 Feb 2016
Feraccru receives marketing authorisation in Europe
26 February 2016 - Shield Therapeutics plc is pleased to announce that the European Commission has granted marketing authorisation across all ...
Posted by Michael Wonder on 24 Feb 2016
EU green light for Lilly's lung cancer drug Portrazza
24 February 2016 - European regulators have approved Eli Lilly’s Portrazza as a treatment for patients with advanced non-small cell lung ...
Posted by Michael Wonder on 24 Sep 2015
Keryx receives European approval for Fexeric (ferric citrate coordination complex) for the treatment of hyperphosphataemia in adults with chronic kidney disease
24 September 2015 - Keryx Biopharmaceuticals, Inc. today announced that the European Commission has approved Fexeric (ferric citrate coordination complex) for ...
Posted by Michael Wonder on 23 Sep 2015
AcelRx Pharmaceuticals reports that the European Commission has granted marketing authorization for Zalviso for treatment of acute moderate-to-severe post-operative pain in adult patients
22 September 2015 - AcelRx Pharmaceuticals, Inc. announced today that the European Commission (EC) has approved Zalviso (15 micrograms sufentanil sublingual ...
Posted by Michael Wonder on 21 Sep 2015
Non-stimulant for ADHD approved in Europe
21 September 2015 - Shire today announced that the European Commission granted Marketing Authorisation for once-daily, non-stimulant Intuniv (guanfacine hydrochloride prolonged ...
Posted by Michael Wonder on 11 Sep 2015
Updated label for Daklinza (daclatasvir) for the 12-week treatment of non-cirrhotic patients with chronic hepatitis C genotype 3 approved by the European Commission
10 September 2015 - Bristol-Myers Squibb Company announced today that the European Commission has approved an updated label for Daklinza for ...
Posted by Michael Wonder on 10 Sep 2015
Santhera receives European marketing authorisation for Raxone in Leber's hereditary optic neuropathy (LHON)
9 September 2015 - Santhera Pharmaceuticals announces the European Commission (EC) has granted marketing authorisation for Raxone as the first approved ...
Posted by Michael Wonder on 04 Sep 2015
Novartis receives EU approval for Farydak, the first in its class of anticancer agents approved for patients with multiple myeloma
4 September 2015 - Novartis announced today that the European Commission has approved Farydak (panobinostat, previously known as LBH589) capsules, in ...
Posted by Michael Wonder on 04 Sep 2015
Novartis wins EU approval for multiple myeloma drug Farydak
4 September 2015 - Novartis AG said on Friday it received European Union approval for Farydak, a treatment for multiple myeloma ...
Posted by Michael Wonder on 03 Sep 2015
Novartis receives EU approval for new Revolade use as first-in-class therapy for patients with severe aplastic anemia
2 September 2015 - Novartis announced today that the European Commission has approved Revolade (eltrombopag olamine) for the treatment of adults ...
Posted by Michael Wonder on 01 Sep 2015
Novartis receives EU approval for Tafinlar and Mekinist, first combination approved for patients with aggressive form of melanoma
1 September 2015 - Novartis today announced that the European Commission has approved the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) ...
Posted by Michael Wonder on 01 Sep 2015
European Commission grants marketing authorisation for Kanuma (sebelipase alfa) for the treatment of patients of all ages with lysosomal acid lipase deficiency (LAL-D)
1 September 2015 - Alexion Pharmaceuticals, Inc. announced today that the European Commission (EC) has approved Kanuma (sebelipase alfa) for long-term ...
Posted by Michael Wonder on 27 Aug 2015
CSL Behring receives marketing authorisation for Respreeza in Europe
25 August 2015 - CSL Behring announced today that the European Commission (EC) has granted marketing authorization in all European Union ...