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RSS FeedPosted by Michael Wonder on 27 Jul 2025
Vertex announces marketing authorisation in Canada for Alyftrek, a once daily next generation CFTR modulator for the treatment of cystic fibrosis
22 July 2025 - Approximately 3,800 people in Canada are now eligible for Alyftrek, with up to 60 people potentially ...
Posted by Michael Wonder on 26 Jul 2025
Sobi announces US FDA approves Doptelet (avatrombopag) for the treatment of thrombocytopenia in paediatric patients one year and older with persistent or chronic immune thrombocytopenia
25 July 2025 - The primary outcome was met in 27.8% of patients, confirming the efficacy in children and adolescents ...
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
Health Canada grants marketing authorisation for Bayer’s Lynkuet (elinzanetant)
25 July 2025 - Authorisation is supported by data from the Phase 3 OASIS clinical trial program evaluating Lynkuet for the ...
Posted by Michael Wonder on 26 Jul 2025
Bayer provides regulatory update on elinzanetant in the US
25 July 2025 - Bayer today announced that the US FDA has notified the company that it has extended the ...
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
Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer
24 July 2025 - The approval is supported by a study involving 453 adults with advanced platinum-resistant cancers of the ovary, ...
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 24 Jul 2025
Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma
23 July 2025 - Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7. ...