Blog
RSS FeedPosted 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
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 20 Sep 2025
Elinzanetant recommended for approval in EU as treatment of moderate to severe vasomotor symptoms
19 September 2025 - Positive opinion by the CHMP is based on the results from the clinical development Phase 3 studies ...
Posted by Michael Wonder on 20 Sep 2025
CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma
19 September 2025 - Subcutaneous Lunsumio has potential to substantially reduce treatment administration time with an approximately one minute injection, compared ...
Posted by Michael Wonder on 20 Sep 2025
Merck receives positive EU CHMP opinion for Enflonsia (clesrovimab) for the prevention of respiratory syncytial virus in infants during their first RSV season
19 September 2025 - If approved by the European Commission, Enflonsia will be the first and only RSV preventive option ...
Posted by Michael Wonder on 19 Sep 2025
Tryngolza (olezarsen) approved in the European Union for familial chylomicronaemia syndrome
19 September 2025 - Sobi and Ionis Pharmaceuticals today announced that Tryngolza (olezarsen) has been approved in the European Union ...
Posted by Michael Wonder on 18 Sep 2025
Alteogen receives European Commission approval for aflibercept biosimilar, Eyluxvi (ALT-L9)
17 September 2025 - Eyluxvi is the second biosimilar approved for Alteogen following the launch of the Herceptin biosimilar in China ...
Posted by Michael Wonder on 18 Sep 2025
Biogen receives European Commission approval for Zurzuvae (zuranolone), the first and only treatment approved for women with postpartum depression in Europe
17 September 2025 - The EC approval of Zurzuvae is based on the SKYLARK study, which demonstrated rapid relief from depressive ...
Posted by Michael Wonder on 15 Sep 2025
EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke
15 September 2025 - This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus) reduced ...
Posted by Michael Wonder on 12 Sep 2025
Johnson & Johnson seeks first EMA approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm
11 September 2025 - Johnson & Johnson today announced the submission of an application to the EMA seeking the first approval ...