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RSS FeedPosted by Michael Wonder on 29 Jun 2023
Esperion announces submission of application for expanded indication with the EMA for Nilemdo (bempedoic acid) tablet and Nustendi (bempedoic acid and ezetimibe) tablet
28 June 2023 - Seeking inclusion of CV risk reduction indications in Europe. ...
Posted by Michael Wonder on 28 Jun 2023
Merck, Ridgeback withdraw COVID drug application in EU
27 June 2023 - Merck and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in ...
Posted by Michael Wonder on 28 Jun 2023
Bristol Myers Squibb receives European Commission approval of Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 June 2023 - Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients ...
Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
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 26 Jun 2023
Revise pharmaceutical legislation, or long-term access to medical breakthroughs for Europeans will be harmed
22 June 2023 - Yesterday, the newly elected Presidency team of the European Federation of Pharmaceutical Industries and Associations convened ...
Posted by Michael Wonder on 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
Posted by Michael Wonder on 24 Jun 2023
Amylyx Pharmaceuticals receives CHMP negative opinion on its conditional marketing authorisation application for AMX0035 for the treatment of ALS in the European Union
23 June 2023 - Amylyx will seek re-examination of its conditional marketing authorisation application. ...
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
Leo Pharma receives positive CHMP opinion for new Adtralza (tralokinumab) injection device
23 June 2023 - CHMP recommends approval of the Adtralza pre-filled pen. ...
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 20 Jun 2023
Legacy Healthcare announces EMA validation of marketing authorisation application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents
19 June 2023 - Legacy Healthcare today announced that its marketing authorisation application to the EMA's CHMP for Coacillium for the ...