26 February 2024 - Recommendation of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial results. ...
23 February 2024 - Positive CHMP opinion is based on pivotal Phase 3 PROTECT study results. ...
23 February 2024 - The EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting. ...
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first ...
23 February 2024 - In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary ...
23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...
19 February 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
26 January 2024 - The EMA’s CHMP recommended three medicines for approval at its January 2024 meeting. ...
22 January 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically ...
15 December 2023 - If approved by the European Commission, patients 12 years of age and older with severe sickle cell ...
11 December 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
13 November 2023 - The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment ...
10 November 2023 - The EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting. ...
6 November 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...