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RSS FeedPosted by Michael Wonder on 11 Sep 2023
EMA publishes agenda for 11-14 September 2023 CHMP meeting
11 September 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Jul 2023
Highlights from the 17-20 July 2023 CHMP meeting
21 July 2023 - The EMA’s CHMP recommended 14 medicines for approval at its July 2023 meeting. ...
Posted by Michael Wonder on 17 Jul 2023
EMA publishes agenda for 17-20 July CHMP meeting
17 July 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 26 Jun 2023
GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
26 June 2023 - GSK today announced that the CHMP of the EMA has issued a positive opinion recommending authorisation ...
Posted by Michael Wonder on 26 Jun 2023
Soliris recommended for approval in the EU by CHMP for children and adolescents with refractory generalised myasthenia gravis
26 June 2023 - The first in class C5 inhibitor reduced disease severity and symptoms with sustained improvements over 26 ...
Posted by Michael Wonder on 26 Jun 2023
Gilead receives CHMP positive opinion for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer
23 June 2023 - Recommendation based on the TROPiCS-02 study showing Trodelvy demonstrated statistically significant and clinically meaningful overall survival in ...
Posted by Michael Wonder on 26 Jun 2023
Jardiance recommended for the treatment of adults with chronic kidney disease in the EU
23 June 2023 - The positive CHMP opinion is based on the landmark EMPA-KIDNEY trial, the largest and broadest dedicated SGLT2 ...
Posted by Michael Wonder on 24 Jun 2023
AbbVie secures positive CHMP opinion for atogepant for the preventive treatment of adults with migraine
23 June 2023 - The positive CHMP opinion is based on results from two pivotal Phase 3 studies evaluating atogepant ...
Posted by Michael Wonder on 24 Jun 2023
Highlights from the 19-22 June 2023 CHMP meeting
23 June 2023 - The EMA’s CHMP recommended two medicines for approval at its June 2023 meeting. ...
Posted by Michael Wonder on 19 Jun 2023
EMA publishes agenda for 19-22 June CHMP meeting
19 June 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 May 2023
Highlights from the CHMP 22-25 May 2023 meeting
26 May 2023 - The EMA’s CHMP recommended two medicines for approval at its May 2023 meeting. ...
Posted by Michael Wonder on 22 May 2023
EMA publishes agenda for 22-25 May 2023 CHMP meeting
22 May 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 28 Apr 2023
CHMP issues positive opinion for futibatinib for the treatment of adults with cholangiocarcinoma
27 April 2023 - Taiho Pharmaceutical announced today that the EMA's CHMP has issued a positive opinion recommending the conditional ...
Posted by Michael Wonder on 27 Apr 2023
UCB receives positive CHMP opinions for bimekizumab for the treatment of adults with psoriatic arthritis and axial spondyloarthritis in the European Union
27 April 2023 - Positive CHMP opinions are supported by data from four Phase 3 studies that evaluated bimekizumab in active ...
Posted by Michael Wonder on 27 Apr 2023
Novartis Cosentyx gains positive CHMP opinion for hidradenitis suppurativa
26 April 2023 - Positive opinion paves way for first new treatment option in hidradenitis suppurativa in nearly a decade. ...