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RSS FeedPosted by Michael Wonder on 31 Jul 2025
EMA CHMP adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant LP.8.1
25 July 2025 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European ...
Posted by Michael Wonder on 29 Jul 2025
BeOne Medicines receives positive CHMP opinion for Tevimbra in neo-adjuvant/adjuvant NSCLC treatment
28 July 2025 - Recommendation based on Phase 3 RATIONALE-315 study, in which Tevimbra demonstrated clinically meaningful and statistically significant improvement ...
Posted by Michael Wonder on 29 Jul 2025
Alteogen receives positive CHMP opinion for aflibercept biosimilar, 'Eyluxvi (ALT-L9)'
28 July 2025 - Upon approval, Eyluxvi will be Alteogen's second biosimilar product, following a Herceptin biosimilar by Alteogen's license ...
Posted by Michael Wonder on 29 Jul 2025
CHMP recommends EU approval of Henlius’ denosumab biosimilar HLX14
28 July 2025 - Shanghai Henlius Biotech announced today that the EMA's CHMP has adopted a positive opinion for HLX14, the ...
Posted by Michael Wonder on 29 Jul 2025
Zevra Therapeutics submits marketing authorisation application to EMA to review arimoclomol for the treatment of Niemann-Pick disease type C
28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...
Posted by Michael Wonder on 26 Jul 2025
Pfizer and BioNTech receive positive CHMP opinion for LP.8.1 adapted COVID-19 vaccine in the European Union
25 July 2025 - Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sub-lineages ...
Posted by Michael Wonder on 26 Jul 2025
Gilead receives positive CHMP opinions under accelerated review from EMA for twice yearly lenacapavir for HIV prevention
25 July 2025 - Positive opinion also received for EMA’s EU-M4all Procedure, designed to facilitate availability in low- and lower-middle-income countries. ...
Posted by Michael Wonder on 26 Jul 2025
Roche provides regulatory update on Elevidys gene therapy for Duchenne muscular dystrophy in the EU
25 July 2025 - Roche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys ...
Posted by Michael Wonder on 26 Jul 2025
Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma
25 July 2025 - Approval based on GMMG-HD7 Phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD ...
Posted by Michael Wonder on 25 Jul 2025
European regulatory authority adopts positive opinion for Novo Nordisk’s Alhemo (concizumab), recommending label expansion to treat haemophilia A and B without inhibitors
25 July 2025 - This positive opinion by the EMA’s CHMP is based on results from the explorer8 trial, which ...
Posted by Michael Wonder on 25 Jul 2025
Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential
25 July 2025 - Next-generation propellant offers 99.9% reduction in global warming potential compared to current propellants. ...
Posted by Michael Wonder on 25 Jul 2025
Donanemab receives positive opinion from the CHMP in early symptomatic Alzheimer's disease
25 July 2025 - Eli Lilly and Company announced today that the EMA's CHMP has issued a positive opinion recommending donanemab ...
Posted by Michael Wonder on 25 Jul 2025
Cabometyx approved in the EU for previously treated advanced neuroendocrine tumours
24 July 2025 - Approval based on pivotal CABINET Phase 3 trial which demonstrated a 77% and 62% reduction in ...
Posted by Michael Wonder on 25 Jul 2025
Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma
24 July 2025 - Two head-to-head Phase 3 trials demonstrated superior efficacy, including overall survival versus a daratumumab-based triplet in DREAMM-7. ...
Posted by Michael Wonder on 23 Jul 2025
European Commission approves Imbruvica (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant
23 July 2025 - Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of ...