26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...
23 February 2024 - If approved, Kalydeco will be the first and only medicine approved in Europe to treat the underlying ...
17 December 2023 - Astellas contributed to the development of a paediatric formulation to treat schistosomiasis as a member of ...
16 November 2023 - IRE) -- Praxis Precision Medicines today announced that the EMA has awarded its Priority Medicines (PRIME) designation ...
17 October 2023 - PRIME eligibility granted based on key positive data from the Phase 2B (RIZE) study and current ...
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...
7 September 2023 - Milestone signifies on-going effort to help prepare for outbreaks of Zaire ebolavirus. ...
29 August 2023 - Approval is based on interim data from ongoing RAINBOWFISH trial showing majority of Evrysdi-treated babies were able ...
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
27 July 2023 - First and only targeted therapy approved for paediatric patients with generalised myasthenia gravis in the EU ...
21 July 2023 - EMA has recommended granting a marketing authorisation in the European Union for Abrysvo, a vaccine to protect ...
21 July 2023 - Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority of Evrysdi treated ...
5 July 2023 - Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible ...