On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®. The updated vaccine targets the LP.8.1 variant of...more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more
The European Medicines Agency (EMA) has announced that it now offers the possibility for simultaneous review of centralized marketing authorization applications (MAAs) and applications for a scientific opinion under Article...more
In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical guidance on nitrosamines. The guidance is...more
On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in therapeutic indications. The...more