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RSS FeedPosted by Michael Wonder on 28 Oct 2025
Koselugo approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1
28 August 2025 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 22 Oct 2025
Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps
22 October 2025 - Approval based on WAYPOINT Phase 3 results demonstrating reduced nasal polyp severity and nasal congestion, near ...
Posted by Michael Wonder on 15 Oct 2025
Corcept submits marketing authorisation application to EMA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 October 2025 - Corcept Therapeutics has submitted a marketing authorisation application to the EMA for relacorilant to treat patients ...
Posted by Michael Wonder on 09 Oct 2025
Ascendis submits marketing authorisation application to the EMA for TransCon CNP for treatment of children with achondroplasia
8 October 2025 - Ascendis Pharma today announced it has submitted a marketing authorisation application to the EMA for TransCon CNP ...
Posted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed ...
Posted by Michael Wonder on 29 Sep 2025
EMA recommends marketing approval of Gobivaz, Alvotech’s proposed biosimilar to Simponi (golimumab) with Advanz Pharma as commercialisation partner
22 September 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 25 Sep 2025
Lilly's Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer's disease
25 September 2025 - Approved for earliest symptomatic stages of disease, demonstrating significant slowing of cognitive and functional decline. ...
Posted by Michael Wonder on 23 Sep 2025
EMA recommends marketing authorisation of AVT03, Alvotech’s proposed biosimilar to Prolia and Xgeva
22 September 2025 - Alvotech today announced that the EMA's CHMP has adopted a positive opinion recommending approval for AVT03, Alvotech’s ...
Posted by Michael Wonder on 22 Sep 2025
Koselugo recommended for approval in the EU by CHMP for plexiform neurofibromas in adults with neurofibromatosis type 1
22 September 2025 - Recommendation based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 22 Sep 2025
Tezspire recommended for approval in the EU by CHMP for chronic rhinosinusitis with nasal polyps
22 September 2025 - Recommendation based on WAYPOINT Phase III trial results showing Tezspire reduced nasal polyp severity and nasal ...
Posted by Michael Wonder on 22 Sep 2025
Dupixent (dupilumab) to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion
22 September 2025 - Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives ...
Posted by Michael Wonder on 21 Sep 2025
KalVista Pharmaceuticals announces European Commission and Swissmedic approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema
19 September 2025 - First European launch of Ekterly expected in Germany Q4, 2025. ...
Posted by Michael Wonder on 21 Sep 2025
First treatment recommended for rare immunoglobulin-related autoimmune disease
19 September 2025 - Uplizna significantly reduced the number of flares in patients with active immunoglobulin G4-related disease. ...
Posted by Michael Wonder on 20 Sep 2025
Merck receives two positive EU CHMP opinions for Keytruda (pembrolizumab), for subcutaneous administration and for new indication for earlier-stage head and neck cancer
19 September 2025 - Positive opinion also granted for Keytruda as part of a peri-operative regimen for the treatment of certain ...