Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...
Posted by Michael Wonder on 05 May 2020
EMA publishes minutes of joint meeting with EUnetHTA - November 2019
5 May 2020 - This was the 18th meeting between the EMA and representatives from the EUnetHTA and attended by the ...
Posted by Michael Wonder on 09 Jan 2020
Human medicines: highlights of 2019
9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...
Posted by Michael Wonder on 17 Apr 2018
Final minutes of December 2017 EMA/EUnetHTA meeting
16 April 2018 - The EMA has published the final minutes from the 15 December 2017 meeting. ...
Posted by Michael Wonder on 26 Apr 2017
EMA publishes withdrawal assessment report for Graspa
25 April 2017 - On 14 November 2016, Erytech Pharma officially notified the CHMP that it wishes to withdraw its application ...
Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades. ...
Posted by Michael Wonder on 17 Jan 2017
Human medicines: highlights of 2016
17 January 2017 - 81 medicines recommended for approval, including 27 new active substances. ...
Posted by Michael Wonder on 22 Dec 2016
EMA publishes EPAR for Venclyxto
22 December 2016 - The EMA has published an EPAR for AbbVie's new BCL inhibitor. ...
Posted by Michael Wonder on 07 Dec 2016
EMA publishes EPAR for Ninlaro
7 December 2016 - The EMA has published a EPAR for Takeda's proteasome inhibitor. ...
Posted by Michael Wonder on 25 Nov 2016
EMA publishes EPAR for Ibrance
25 November 2016 - The EMA has published an EPAR for Pfizer's new cyclin-dependent kinase (CDK4/6) inhibitor. ...
Posted by Michael Wonder on 23 Nov 2016
EMA publishes EPAR for Lartruvo
23 November 2016 - The EMA has published a EPAR for Eli Lilly's platelet derived growth factor receptor antagonist. ...
Posted by Michael Wonder on 12 Oct 2016
EMA publishes EPAR for Cabometyx (cabozantinib maleate)
12 October 2016 - The EMA has published an EPAR for Ipsen's Cabometyx. ...
Posted by Michael Wonder on 09 Oct 2016
Human medicines highlights - September 2016
7 October 2016 - Key information for patients, consumers and healthcare professionals published monthly by the EMA. ...
Posted by Michael Wonder on 30 Sep 2016
EMA publishes EPAR for Truberzi
29 September - The EMA has published an EPAR for Allergan's Truberzi (eluxadoline). ...
Posted by Michael Wonder on 29 Sep 2016
EMA publishes EPAR for Nordimet
29 September 2016 - The EMA has published an EPAR for Nordic Pharma's Nordimet. ...