Blog
RSS FeedPosted by Michael Wonder on 28 Jun 2025
Eylea 8 mg with extended 6 month treatment interval approved in the EU
27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...
Posted by Michael Wonder on 28 Jun 2025
Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA
27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 27 Jun 2025
Sephience (sepiapterin) granted marketing authorisation by the European Commission for the treatment of children and adults living with phenylketonuria
23 June 2025 - Launch to be initiated in Germany. ...
Posted by Michael Wonder on 27 Jun 2025
Philogen provides update on marketing authorisation application for Nidlegy in the European Union
24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA ...
Posted by Michael Wonder on 26 Jun 2025
BeOne Medicines receives positive CHMP opinion for tablet formulation of Brukinsa
25 June 2025 - BeOne Medicines today announced that the CHMP of the EMA issued a positive opinion recommending approval ...
Posted by Michael Wonder on 25 Jun 2025
Linerixibat accepted for review by the EMA for cholestatic pruritus in patients with primary biliary cholangitis
23 June 2025 - Submission based on data from positive GLISTEN Phase 3 trial ...
Posted by Michael Wonder on 24 Jun 2025
Ozempic receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and co-morbidities
23 June 2025 - Pending a decision from the European Commission, Ozempic (once weekly semaglutide) will have the broadest approved label ...
Posted by Michael Wonder on 24 Jun 2025
EMA recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept)
23 June 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP adopted a positive opinion recommending approval for ...
Posted by Michael Wonder on 24 Jun 2025
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma
23 June 2025 - Recommendation based on GMMG-HD7 Phase 3 study demonstrating that Sarclisa with bortezomib, lenalidomide, and dexamethasone induction treatment significantly ...
Posted by Michael Wonder on 21 Jun 2025
European Medicines Agency CHMP recommends EU approval of Partner Therapeutics Imreplys (sargramostim, rhu GM-CSF) to treat exposure to myelosuppressive doses of radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome)
20 June 2025 - Partner Therapeutics today announced that the CHMP of the EMA has recommended approval of PTx's marketing authorisation ...
Posted by Michael Wonder on 17 Jun 2025
Averoa receives European marketing authorisation for Xoanacyl, an oral therapy for chronic kidney disease
16 June 2025 - AVEROA actively seeking strategic partners and investors to bring Xoanacyl to European patients and unlock full ...
Posted by Michael Wonder on 16 Jun 2025
EMA publishes agenda for 16-19 June 2025 CHMP meeting
16 June 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Jun 2025
EMA 2024 annual report is published
10 June 2025 - The EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions ...
Posted 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 ...