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RSS FeedPosted by Michael Wonder on 16 Apr 2025
Leqembi (lecanemab) is the first medicine that slows progression of early Alzheimer’s disease to be authorised in the European Union
15 Apil 2025 - Eisai and Biogen announced today that the European Commission has granted the amyloid-beta monoclonal antibody Leqembi (lecanemab) ...
Posted by Michael Wonder on 14 Apr 2025
European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
14 April 2025 - Approval based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction ...
Posted by Michael Wonder on 09 Apr 2025
Bayer files for approval of aflibercept 8 mg for treatment of retinal vein occlusion in EU
8 April 2025 - Bayer has submitted an application to the EMA seeking approval of aflibercept 8 mg (114.3 mg/ml solution ...
Posted by Michael Wonder on 08 Apr 2025
Datroway approved in the EU for patients with previously treated metastatic HR positive, HER2 negative breast cancer
8 April 2025 - Second DXd antibody drug conjugate approved in EU based on Daiichi Sankyo’s DXd technology ...
Posted by Michael Wonder on 08 Apr 2025
AbbVie announces European Commission approval of Rinvoq (upadacitinib) for the treatment of adults with giant cell arteritis
8 April 2025 - This marks the eighth approved indication for Rinvoq in the EU. ...
Posted by Michael Wonder on 08 Apr 2025
European Commission approves expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis
7 April 2025 - Approximately 4,000 people living with cystic fibrosis in the European Union are newly eligible for a ...
Posted by Michael Wonder on 07 Apr 2025
European Commission approves subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
7 April 2025 - European Commission approval based on positive results from the Phase 3 PALOMA-3 study. ...
Posted by Michael Wonder on 04 Apr 2025
Imfinzi-based peri-operative regimen approved in the EU for resectable non-small cell lung cancer
4 April 2025 - Approval based on AEGEAN Phase 3 trial results which showed a 32% reduction in the risk ...
Posted by Michael Wonder on 04 Apr 2025
Enhertu approved in the EU as first HER2 directed therapy for patients with HR positive, HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
4 April 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 04 Apr 2025
Helsinn submits a new formulation of Akynzeo to the EMA
2 April 2025 - Helsinn today announced the submission of a new formulation for Akynzeo to the EMA. ...
Posted by Michael Wonder on 04 Apr 2025
Bristol Myers Squibb receives positive CHMP opinion for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 March 2025 - A decision on the EU Opdivo extension of marketing authorisation is expected by 2 June 2025 ...
Posted by Michael Wonder on 03 Apr 2025
Averoa receives positive opinion from the EMA for Xoancyl, an oral therapy for chronic kidney disease
2 April 2025 - Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure. ...
Posted by Michael Wonder on 02 Apr 2025
Sydnexis announces positive CHMP opinion in Europe for SYD-101 for slowing the progression of paediatric myopia
1 April 2025 - Santen is Sydnexis’ licensing partner to commercialise SYD-101 within the EMEA region upon issuance of a ...
Posted by Michael Wonder on 02 Apr 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above
1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...
Posted by Michael Wonder on 01 Apr 2025
GRIN Therapeutics receives PRIME designation from EMA for radiprodil in the treatment of GRIN related neurodevelopmental disorder
1 April 2025 - GRIN Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to radiprodil, the company's ...