Blog
RSS FeedPosted by Michael Wonder on 18 Nov 2025
High dose regimen of nusinersen receives positive CHMP opinion for the treatment of spinal muscular atrophy
17 November 2025 - Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen ...
Posted by Michael Wonder on 15 Nov 2025
CHMP positive opinion for Waskyra, a gene therapy for the treatment of Wiskott-Aldrich syndrome
14 November 2025 - Fondazione Telethon announces the positive opinion issued by the CHMP of the EMA, recommending marketing authorisation in ...
Posted by Michael Wonder on 15 Nov 2025
Highlights from the 10-13 November 2025 CHMP meeting
14 November 2025 - The EMA’s CHMP recommended ten medicines for approval at its November 2025 meeting. ...
Posted by Michael Wonder on 15 Nov 2025
Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes
14 November 2025 - The EMA’s CHMP has adopted a positive opinion recommending the approval of Teizeild (teplizumab) to delay ...
Posted 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 18 Oct 2025
CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis
17 October 2025 - Positive recommendation based on Phase 2 NOBILITY and Phase 3 REGENCY data showing Gazyva/Gazyvaro’s superiority over standard ...
Posted by Michael Wonder on 18 Oct 2025
CHMP recommends EU approval of Brinsupri (brensocatib) for the treatment of non-cystic fibrosis bronchiectasis
17 October 2025 - Brinsupri was reviewed under CHMP's accelerated assessment pathway as it is considered of major interest for public ...
Posted by Michael Wonder on 18 Oct 2025
Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia
17 October 2025 - Recommendation based on LUNA 3 Phase 3 study demonstrating rapid and durable platelet response and significant improvements ...
Posted by Michael Wonder on 17 Oct 2025
Highlights from the 13-16 October 2025 CHMP meeting
17 October 2025 - The EMA’s CHMP has recommended two medicines for approval at its October 2025 meeting. ...
Posted by Michael Wonder on 17 Oct 2025
Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus
17 October 2025 - Recommendation based on TULIP-SC Phase III trial results showing first in class Saphnelo reduced disease activity ...
Posted by Michael Wonder on 17 Oct 2025
Libtayo (cemiplimab) recommended for EU approval by the CHMP for adjuvant treatment of cutaneous squamous cell carcinoma with a high risk of recurrence after surgery and radiation
17 October 2025 - Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the ...
Posted by Michael Wonder on 17 Oct 2025
Novartis Scemblix receives positive CHMP opinion for the treatment of adults with newly diagnosed CML
17 October 2025 - If approved, Scemblix will be indicated for adults with chronic myeloid leukaemia (CML), both newly diagnosed and ...
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. ...