Blog
RSS FeedPosted 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 13 Oct 2025
EMA publishes agenda for 13-16 October 2025 CHMP meeting
13 October 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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
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
Highlights from the 15-18 September 2025 CHMP meeting
19 September 2025 - The EMA’s CHMP has recommended 14 medicines for approval at its September 2025 meeting. ...
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 ...
Posted by Michael Wonder on 31 Jul 2025
EMA CHMP adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant LP.8.1
25 July 2025 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European ...