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RSS FeedPosted 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
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 08 Jun 2023
European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults
7 June 2023 - The authorisation is based on Phase 3 efficacy data in older adults. ...
Posted by Michael Wonder on 07 Jun 2023
UCB receives new European Commission approvals for Bimzelx (bimekizumab) for the treatment of psoriatic arthritis and axial spondyloarthritis
7 June 2023 - Bimekizumab is the first and only IL-17A and IL-17F inhibitor approved in the European Union for active ...
Posted by Michael Wonder on 06 Jun 2023
Fennec Pharmaceuticals announces European Commission marketing authorisation for Pedmarqsi (sodium thiosulphate) to reduce the risk of hearing loss in paediatric oncology patients
6 June 2023 - Pedmarqsi is the first and only approved therapy in the European Union for reducing the risk of ...
Posted by Michael Wonder on 06 Jun 2023
Novartis receives European approval for Cosentyx as first and only IL-17A inhibitor for hidradenitis suppurativa
1 June 2023 - European approval is based on robust Phase 3 data showing Cosentyx provided rapid symptom relief from as ...
Posted by Michael Wonder on 05 Jun 2023
TG Therapeutics announces European Commission approval for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
1 June 2023 - TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the European Commission (EC) has granted approval of ...
Posted by Michael Wonder on 01 Jun 2023
Samsung Bioepis obtains European Commission approval for Soliris biosimilar
30 May 2023 - Samsung Bioepis said that the European Commission has granted marketing authorization for Epysqli, a biosimilar referencing ...
Posted by Michael Wonder on 30 May 2023
Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU
26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as ...