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 ...
27 March 2024 - PRIME status is supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin. ...
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
22 March 2024 - The EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. ...
22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...