Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 01 Apr 2025
Highlights from the 24-27 March 2025 CHMP meeting
28 March 2025 - The EMA’s CHMP recommended five medicines for approval at its March 2025 meeting. ...
Posted by Michael Wonder on 01 Apr 2025
European Commission approves Pfizer’s RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease
1 April 2025 - Abrysvo is the first and only RSV vaccine approved in the European Union for non-pregnant adults ...
Posted by Michael Wonder on 01 Apr 2025
Tivdak (tisotumab vedotin) approved by European Commission for previously treated recurrent or metastatic cervical cancer
31 March 2025 - In the global Phase 3 innovaTV 301 clinical trial Tivdak demonstrated superior overall survival compared to chemotherapy. ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 31 Mar 2025
Imfinzi approved in the US as first and only peri-operative immunotherapy for patients with muscle-invasive bladder cancer
31 March 2025 - Based on NIAGARA Phase 3 trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 31 Mar 2025
Lilly’s statement about the CHMP opinion issued for donanemab
28 March 2025 - The EMA's CHMP issued an opinion that does not recommend Eli Lilly's donanemab be granted marketing ...