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RSS FeedPosted by Michael Wonder on 18 Dec 2022
Finerenone receives positive CHMP opinion for EU label extension for broad range of patients with chronic kidney disease and type 2 diabetes
16 December 2022 - CHMP opinion is based on the results from the Phase 3 FIGARO-DKD cardiovascular outcomes trial in patients ...
Posted by Michael Wonder on 18 Dec 2022
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
16 December 2022 - The positive CHMP opinion is based on the results of the HAVEN 6 trial, which demonstrated effective ...
Posted by Michael Wonder on 16 Dec 2022
Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic oesophagitis
16 December 2022 - If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 ...
Posted by Michael Wonder on 16 Dec 2022
CSL receives positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with haemophilia B
16 December 2022 - Regulatory milestone moves CSL one step closer to bringing the promise of gene therapy for haemophilia ...
Posted by Michael Wonder on 13 Dec 2022
EMA publishes agenda for the 12-15 December CHMP meeting
12 December 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 11 Nov 2022
Meeting highlights from the 7-10 November 2022 CHMP meeting
11 November 2022 - The EMA’s CHMP recommended four medicines for approval at its November 2022 meeting. ...
Posted by Michael Wonder on 11 Nov 2022
Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis
11 November 2022 - Recommendation is based on data from two pivotal trials showing Dupixent significantly improved itch, skin lesions and ...
Posted by Michael Wonder on 15 Oct 2022
Highlights from the 10-13 October 2022 CHMP meeting
14 October 2022 - The EMA’s CHMP recommended 10 medicines for approval at its October 2022 meeting. ...
Posted by Michael Wonder on 11 Oct 2022
EMA publishes minutes of bilateral EMA – EUnetHTA meeting (June 2022)
11 October 2022 - The chairs welcome participants to the first bilateral under the new Work Plan between EUnetHTA 21 ...
Posted by Michael Wonder on 10 Oct 2022
EMA publishes agenda for 10-13 October 2022 CHMP meeting
10 October 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Sep 2022
CHMP adopts positive opinion for Mycapssa for the treatment of acromegaly
16 September 2022 - Positive opinion based on MPOWERED Phase 3 trial. ...
Posted by Michael Wonder on 19 Sep 2022
AbbVie secures positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderate to severe Crohn's disease
19 September 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 17 Sep 2022
Highlights from the 12-15 September 2022 CHMP meeting
16 September 2022 - 12 new medicines recommended for approval. ...
Posted by Michael Wonder on 16 Sep 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19
16 September 2022 - Recommendation based on TACKLE Phase 3 treatment data showing reduced risk of severe COVID-19 or death. ...
Posted by Michael Wonder on 16 Sep 2022
CHMP recommends approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants
16 September 2022 - Recommendation is based on the Beyfortus clinical trial program which demonstrated protection against medically attended lower respiratory ...