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RSS FeedPosted by Michael Wonder on 19 Nov 2025
Lynkuet (elinzanetant) approved in the EU for the treatment of moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer
19 November 2025 - The European Commission has granted marketing authorisation in the European Union for elinzanetant, under the brand name ...
Posted by Michael Wonder on 19 Nov 2025
Libtayo (cemiplimab) approved in the European Union as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with high risk of recurrence after surgery and radiation
19 November 2025 - Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
19 November 2025 - Roche announced today that the European Commission has granted conditional marketing authorisation of Lunsumio (mosunetuzumab) subcutaneous for ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Brinsupri (brensocatib) as the first and only treatment approved for non-cystic fibrosis bronchiectasis in the European Union
18 November 2025 - Brinsupri was reviewed under EMA's accelerated assessment pathway as it is considered of major interest for public ...
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 11 Nov 2025
EMA publishes agenda for 10-13 November 2025 CHMP meeting
10 November 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 04 Nov 2025
Chiesi Global Rare Diseases and Protalix BioTherapeutics seek re-examination from the EMA for the negative opinion for Elfabrio (pegunigalsidase alfa) alternative dosing regimen of every four weeks in the EU
3 November 2025 - Every two weeks remains approved as a dosing regimen of Elfabrio in the EU. ...
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 23 Oct 2025
Electra Therapeutics receives FDA breakthrough therapy and EMA priority medicines designations for ELA026 in secondary haemophagocytic lymphohistiocytosis
22 October 2025 - Electra Therapeutics today announced that ELA026 has received US FDA breakthrough therapy designation and EMA Priority ...
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. ...