Blog
RSS FeedPosted by Michael Wonder on 01 Mar 2025
Linvoseltamab recommended for EU approval by the CHMP to treat relapsed/refractory multiple myeloma
28 February 2025 - Regeneron Pharmaceuticals today announced that the EMA's CHMP has adopted a positive opinion recommending conditional marketing ...
Posted by Michael Wonder on 26 Feb 2025
EMA accepts marketing authorisation application for ND0612, an investigational treatment for motor fluctuations in Parkinson’s disease
21 February 2025 - Mitsubishi Tanabe Pharma today announced the EMA has accepted for review the marketing authorisation application for ...
Posted by Michael Wonder on 25 Feb 2025
EMA validates Gilead’s marketing authorisation application and EU-Medicines for all application for twice yearly lenacapavir for HIV prevention
24 February 2025 - One application seeks European Commission authorisation; other application would facilitate availability in low and lower middle income ...
Posted by Michael Wonder on 21 Feb 2025
EMA validates indication extension application for Aspaveli for treatment of C3G and primary IC-MPGN
20 February 2025 - Sobi and Apellis Pharmaceuticals today announced the EMA has validated an indication extension application for Aspaveli (pegcetacoplan) ...
Posted by Michael Wonder on 16 Feb 2025
Galderma’s Nemluvio (nemolizumab) approved in the European Union for moderate to severe atopic dermatitis and prurigo nodularis
14 February 2025 - This approval from the European Commission is based on robust results from the Phase 3 OLYMPIA and ...
Posted by Michael Wonder on 11 Feb 2025
Bayer files for approval of extended 6 month treatment interval for Eylea 8 mg in the EU
10 February 2025 - Bayer submitted an application to the EMA to expand treatment intervals of up to 6 months with ...
Posted by Michael Wonder on 08 Feb 2025
Bio-Thera Solutions announces regulatory filing acceptance for BAT2506, a proposed biosimilar to Simponi, in the European Union
7 February 2025 - The BAT2506 marketing authorisation application is based on a robust analytical, non-clinical and clinical data package comparing ...
Posted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 05 Feb 2025
Gilead submits marketing authorisation applications to EMA for twice yearly lenacapavir for HIV prevention
3 February 2025 - One application seeks European Commission authorisation; other application would help facilitate availability in low and lower middle ...
Posted by Michael Wonder on 04 Feb 2025
Fondazione Telethon submits EU marketing authorisation application for etuvetidigene autotemcel gene therapy for the treatment of Wiskott-Aldrich syndrome
3 February 2025 - Fondazione Telethon announced that it has submitted the marketing authorisation application for the gene therapy - etuvetidigene ...
Posted by Michael Wonder on 29 Jan 2025
Depemokimab accepted for review by the EMA for use in asthma with type 2 inflammation and CRSwNP
28 January 2025 - If approved, depemokimab will be the first ultra long-acting biologic with 6 month dosing. ...
Posted by Michael Wonder on 28 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by EMA
27 January 2025 - If approved, the new presentation will offer a convenient administration option to healthcare professionals. ...
Posted by Michael Wonder on 28 Jan 2025
ImmunityBio announces EMA acceptance of marketing authorisation application for Anktiva for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
27 January 2025 - Submission is based on the on-going QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive ...
Posted by Michael Wonder on 25 Jan 2025
X4 Pharmaceuticals announces EMA validation of marketing authorisation application for mavorixafor - licenced to Norgine for commercialisation in Europe
24 January 2025 - Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 ...
Posted by Michael Wonder on 23 Jan 2025
FDA and EMA accept applications for higher dose regimen of nusinersen in spinal muscular atrophy
23 January 2025 - Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher ...