26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
24 April 2024 - Conditional marketing authorisation is based on statistically significant and clinically meaningful results from the Phase 3 ...
23 April 2024 - Averoa announces the submission of a marketing authorisation application to the EMA for Ferric Citrate Coordination ...
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
23 April 2024 - ALPHA Phase 3 trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris ...
23 April 2024 - EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines ...
22 April 2024 - Emblaveo was reviewed under EMA accelerated assessment procedure, used when a pharmaceutical product is of major ...
22 April 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
22 April 2024 - Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD ...
5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval ...
2 April 2024 - Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled ...
28 March 2024 - First marketing authorisation submission for sepiapterin with additional global submissions to follow in 2024. ...
27 March 2024 - Otsuka Pharmaceutical announces that its subsidiary Otsuka Pharmaceutical Europe and Lundbeck announced that the European Commission ...
28 March 2024 - Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung ...