Blog
RSS FeedPosted by Michael Wonder on 06 Jul 2023
Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345
5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...
Posted by Michael Wonder on 10 May 2023
Reforming EU and national orphan drug regulations to improve outcomes for patients with rare diseases
9 May 2023 - In Europe, the number of approvals for new drugs targeting rare diseases (orphan drugs) has risen ...
Posted by Michael Wonder on 25 Jan 2021
EMA publishes agenda for 25-29 January CHMP meeting
25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Nov 2020
Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia
5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...
Posted by Michael Wonder on 26 Mar 2019
Forxiga approved in Europe for type 1 diabetes mellitus
25 March 2019 - Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for adults ...
Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...