Blog
RSS FeedPosted 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 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 14 Jun 2025
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA to expand use in adults 18 years and older
13 June 2025 - Regulatory decision anticipated H1, 2026. ...
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 12 Jun 2025
Oxford vaccine against deadly Nipah virus granted EMA PRIME designation
11 June 2025 - The University of Oxford’s vaccine to protect people from deadly Nipah virus has been granted support from ...
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
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
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 05 Jun 2025
Roche’s Evrysdi tablet approved by European Commission as first and only for spinal muscular atrophy
4 June 2025 - Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with ...
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, ...