Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
Posted by Michael Wonder on 02 Mar 2021
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...
Posted by Michael Wonder on 17 May 2018
FDA faster than global peers at approving new drugs
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
Posted by Michael Wonder on 30 Apr 2018
Access to biosimilars in EU expected to continue to outpace US and Canada
27 April 2018 - Biosimilar experts from across the EU continued to show how rapidly biosimilars have gained market share, ...
Posted by Michael Wonder on 26 Apr 2018
Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada
26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...
Posted by Michael Wonder on 29 Mar 2018
Shire reports regulatory milestones for investigational hereditary angioedema treatment lanadelumab
29 March 2018 - Filings are supported by data from HELP, the pivotal Phase 3 efficacy and safety study. ...
Posted by Michael Wonder on 16 Nov 2017
Akcea and Ionis announce acceptance of marketing applications in US, EU and Canada for volanesorsen for the treatment of FCS
15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...
Posted by Michael Wonder on 06 Jun 2017
Workshop: addressing unmet needs of children with pulmonary arterial hypertension
6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...