Blog
RSS FeedPosted by Michael Wonder on 10 Jun 2025
Alnylam receives European Commission approval for Amvuttra (vutrisiran) for the treatment of ATTR amyloidosis with cardiomyopathy
9 June 2025 - Decision follows recent authorisations in the US and Brazil. ...
Posted by Michael Wonder on 07 Jun 2025
European Commission approves Duvyzat for the treatment of Duchenne muscular dystrophy
6 June 2025 - The approval is based on Phase 3 EPIDYS trial data that demonstrated meaningful treatment benefits in ambulant ...
Posted by Michael Wonder on 06 Jun 2025
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
Posted by Michael Wonder on 06 Jun 2025
Sydnexis announces European Commission approval of SYD-101, the first and only pharmaceutical treatment for slowing the progression of paediatric myopia
5 June 2025 - Exclusive licensing partner Santen will commercialise SYD-101 under the brand name Ryjunea in the EU. ...
Posted by Michael Wonder on 05 Jun 2025
Roche’s Evrysdi tablet approved by European Commission as first and only for spinal muscular atrophy
4 June 2025 - Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with ...
Posted by Michael Wonder on 03 Jun 2025
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with newly diagnosed stage IIb/III/IV Hodgkin lymphoma in combination with ECADD
3 June 2025 - Approval based on positive results from the Phase 3 HD21 trial for stage IIb with risk factors/III/IV ...
Posted by Michael Wonder on 28 May 2025
Bristol Myers Squibb receives European Commission approval for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 May 2025 - Approval is based on results from the Phase 3 CheckMate -67T clinical trial which demonstrated non-inferiority in ...
Posted by Michael Wonder on 27 May 2025
BeiGene receives positive CHMP opinion for Tevimbra as a first-line treatment for nasopharyngeal cancer
27 May 2025 - Positive opinion for Tevimbra in combination with chemotherapy as a first-line treatment of nasopharyngeal cancer based ...
Posted by Michael Wonder on 27 May 2025
Imfinzi recommended for approval in the EU by CHMP as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
27 May 2025 - Recommendation based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 27 May 2025
Eylea 8 mg with extended 6 month treatment interval recommended for approval in EU
23 May 2025 - CHMP opinion is based on the findings from the pivotal clinical trials PULSAR in neovascular (wet) ...
Posted by Michael Wonder on 25 May 2025
Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma
23 May 2025 - Positive opinion supported by superior efficacy shown in two head-to-head Phase 3 trials, including overall survival in ...
Posted by Michael Wonder on 25 May 2025
SpringWorks Therapeutics receives positive CHMP opinion for mirdametinib for the treatment of adult and paediatric patients with NF1-PN
23 May 2025 - If approved, mirdametinib is expected to be the first and only therapy in the European Union with ...
Posted by Michael Wonder on 16 May 2025
BMS receives European Commission approval for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo for resectable, high risk non-small cell lung cancer with PD-L1 expression ≥1%
16 May 2025 - Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared ...
Posted by Michael Wonder on 08 May 2025
European Commission approves Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
7 May 2025 - Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ...
Posted by Michael Wonder on 28 Apr 2025
Lynozyfic (linvoseltamab) approved in the European Union for the treatment of relapsed/refractory multiple myeloma
28 April 2025 - Regeneron Pharmaceuticals today announced that the European Commission has granted conditional marketing approval of Lynozyfic (linvoseltamab) to ...