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RSS FeedPosted by Michael Wonder on 04 Mar 2026
SpliSense granted EMA EARLY PRIME designation for SPL84 in cystic fibrosis
3 March 2026 - SpliSense today announced that the EMA has granted early Priority Medicines (e-PRIME) designation to SPL84 for ...
Posted by Michael Wonder on 01 Mar 2026
EMA CHMP recommends EU approval of Henlius’ pertuzumab biosimilar HLX11
27 February 2026 - Shanghai Henlius Biotech announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 28 Feb 2026
Highlights from the 23-26 February 2026 CHMP meeting
27 February 2026 - The EMA’s CHMP has recommended 12 medicines for approval at its February 2026 meeting. ...
Posted by Michael Wonder on 28 Feb 2026
Asieris announces EMA accepts marketing authorisation application for APL-1702
27 February 2026 - Asieris Pharmaceuticals announced today that its marketing authorisation application for APL-1702 (Cevira) for the treatment of high ...
Posted by Michael Wonder on 28 Feb 2026
Photocure partner Asieris announces that EMA has accepted marketing authorisation application for Cevira in Europe
27 February 2026 - Photocure announces that its partner Asieris Pharmaceuticals communicated today that its marketing authorisation application for Cevira (APL-1702) ...
Posted by Michael Wonder on 27 Feb 2026
Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata
27 February 2026 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for Olumiant ...
Posted by Michael Wonder on 27 Feb 2026
Dupixent (dupilumab) recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment
27 February 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the EMA’s CHMP adopted a positive opinion recommending the approval ...
Posted by Michael Wonder on 27 Feb 2026
Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria
27 February 2026 - Novartis announced today that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 23 Feb 2026
EMA publishes agenda for 23-26 February 2026 CHMP meeting
23 February 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Feb 2026
Sandoz confirms European Commission approval for Ranluspec (ranibizumab)
23 February 2026 - Launch expected second half of 2026; potential to expand access to life-changing treatment option for European patients. ...
Posted by Michael Wonder on 21 Feb 2026
Aumorlertinib mesylate tablets approved in the EU as monotherapy
20 February 2026 - Hansoh Pharmaceutical is pleased to announce that, on 12 February 2026, aumolertinib mesylate tablets have been ...
Posted by Michael Wonder on 19 Feb 2026
Enhertu type II variation application validated in the EU as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
19 February 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease ...
Posted by Michael Wonder on 19 Feb 2026
ImmunityBio receives authorisation from the European Commission for Anktiva with BCG for non-muscle invasive bladder cancer carcinoma in situ, expanding global access to 33 countries
18 February 2026 - ImmunityBio today announced that the European Commission has granted conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept) ...
Posted by Michael Wonder on 18 Feb 2026
Moderna receives European Commission marketing authorisation for COVID-19 vaccine mNEXSPIKE
17 February 2026 - mNEXSPIKE is the third Moderna vaccine authorised in the European Union, strengthening the Company's respiratory vaccine ...
Posted by Michael Wonder on 18 Feb 2026
Telix submits European marketing authorisation application for TLX101-Px for brain cancer imaging
18 February 2026 - Telix today announces that it has submitted a marketing authorisation application in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, ...