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RSS FeedPosted 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
FDA approves Apellis’ Empaveli (pegcetacoplan) as the first C3G and primary IC-MPGN treatment for patients 12 and older
28 July 2025 - Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence. ...
Posted by Michael Wonder on 29 Jul 2025
PTC Therapeutics announces FDA approval of Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria
28 July 2025 - Broad labelling inclusive of all disease subtypes for individuals 1 month of age and older. ...
Posted by Michael Wonder on 29 Jul 2025
FDA approves Skytrofa (lonapegsomatropin-tcgd) for the once weekly treatment of adults with growth hormone deficiency
28 July 2025 - On track to initiate basket trial for idiopathic short stature, SHOX deficiency, Turner syndrome, and short ...
Posted by Michael Wonder on 28 Jul 2025
Highlights from the 21-24 July 2025 CHMP meeting
25 July 2025 - The EMA’s CHMP recommended 13 medicines for approval at its July 2025 meeting. ...
Posted 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
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, ...