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RSS FeedPosted by Michael Wonder on 24 Mar 2024
Highlights from the 18-21 March 2024 CHMP meeting
22 March 2024 - The EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. ...
Posted by Michael Wonder on 22 Mar 2024
Astellas receives positive CHMP opinion for Xtandi in additional recurrent early prostate cancer treatment setting
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...
Posted by Michael Wonder on 22 Mar 2024
Outlook Therapeutics receives European Union positive CHMP opinion for ONS-5010 as a treatment for wet AMD
22 March 2024 - Positive opinion serves as a basis for final decision for potential authorisation from the European Commission ...
Posted by Michael Wonder on 22 Mar 2024
Novartis Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria
22 March 2024 - Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior haemoglobin improvement in the ...
Posted by Michael Wonder on 22 Mar 2024
Awiqli (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities
21 March 2024 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 22 Mar 2024
UCB receives positive CHMP opinion for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa
22 March 2024 - Positive CHMP opinion is supported by data from the two Phase 3 studies, BE HEARD I ...
Posted by Michael Wonder on 18 Mar 2024
EMA publishes agenda for 18-21 March 2024 CHMP meeting
18 March 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 26 Feb 2024
BeiGene receives positive CHMP opinion for tislelizumab as treatment for non-small-cell lung cancer
26 February 2024 - Recommendation based on results of three Phase 3 clinical trials demonstrating benefit of tislelizumab as a first- ...
Posted by Michael Wonder on 26 Feb 2024
Voydeya recommended for approval in the EU by CHMP as add-on treatment to ravulizumab or eculizumab for adults with PNH who have residual haemolytic anaemia
26 February 2024 - Recommendation of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial results. ...
Posted by Michael Wonder on 26 Feb 2024
CSL Vifor and Travere Therapeutics announce sparsentan receives positive CHMP opinion for the treatment of IgA nephropathy
23 February 2024 - Positive CHMP opinion is based on pivotal Phase 3 PROTECT study results. ...
Posted by Michael Wonder on 26 Feb 2024
Highlights from the 19-22 February 2024 CHMP meeting
23 February 2024 - The EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting. ...
Posted by Michael Wonder on 24 Feb 2024
First oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first ...
Posted by Michael Wonder on 24 Feb 2024
Bristol Myers Squibb receives positive CHMP opinion for Reblozyl (luspatercept) for treatment of adults with transfusion-dependent anaemia due to low- to intermediate-risk myelodysplastic syndromes
23 February 2024 - In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary ...
Posted by Michael Wonder on 24 Feb 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence
23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...
Posted by Michael Wonder on 19 Feb 2024
EMA publishes agenda for 19-22 February 2024 CHMP meeting
19 February 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...