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 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 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 20 Jun 2025
Zemcelpro (UM171 cell therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells
19 June 2025 - ExCellThera announced today the CHMP of the EMA has adopted a positive opinion, recommending granting conditional marketing ...
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 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
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 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 03 Jun 2025
MaaT Pharma submits marketing authorisation application to the EMA for Xervyteg (MaaT013) in acute graft versus host disease
2 June 2025 - The marketing authorisation application submitted to the EMA is based on data from the Pivotal ARES study, evaluating ...
Posted by Michael Wonder on 03 Jun 2025
Zealand Pharma submits marketing authorisation application to the EMA for glepaglutide in short bowel syndrome
2 June 2025 - Zealand Pharma today announced the submission of a marketing authorisation application to the EMA for glepaglutide, ...