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RSS FeedPosted by Michael Wonder on 14 Feb 2025
Novartis receives Health Canada approval for Fabhalta oral treatment for adult patients with paroxysmal nocturnal haemoglobinuria
13 February 2025 - Fabhalta is the first oral monotherapy for previously treated and treatment naïve adults with paroxysmal nocturnal haemoglobinuria. ...
Posted by Michael Wonder on 13 Feb 2025
FDA approves Roche’s Evrysdi tablet as first and only tablet for spinal muscular atrophy
12 February 2025 - New tablet formulation may provide greater freedom and independence for people with spinal muscular atrophy thanks ...
Posted by Michael Wonder on 12 Feb 2025
FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a ...
Posted by Michael Wonder on 11 Feb 2025
Biohaven announces FDA acceptance and priority review of troriluzole new drug application for the treatment of spinocerebellar ataxia
11 February 2025 - Troriluzole demonstrated a 50-70% slowing of spinocerebellar ataxia disease progression on the primary and secondary outcome measures at ...
Posted by Michael Wonder on 11 Feb 2025
Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma
11 February 2025 - FDA decision expected by 10 July 2025. ...
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 07 Feb 2025
FDA grants priority review to Insmed's brensocatib for treatment of bronchiectasis
6 February 2025 - Brensocatib would be the first and only available treatment for bronchiectasis and first DPP1 inhibitor, if ...
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
Astellas submits new drug application for conditional approval of avacincaptad pegol for geographic atrophy in Japan
5 February 2025 - Ministry of Health, Labour and Welfare to evaluate avacincaptad pegol as potential first and only treatment for ...
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 03 Feb 2025
US FDA accepts biologics license application for HLX11, biosimilar candidate of Perjeta (pertuzumab)
2 February 2025 - Shanghai Henlius Biotech announced that the US FDA has accepted the biologics license application for HLX11, ...
Posted by Michael Wonder on 02 Feb 2025
US FDA approves Celltrion's Avtozma (tocilizumab-anoh), a biosimilar to Actemra
30 January 2025 - Approval was received for multiple indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic ...
Posted by Michael Wonder on 30 Jan 2025
Ironwood Pharmaceuticals initiates apraglutide NDA submission
29 January 2025 - Initiated rolling new drug application submission, now to include long-term extension data given continued clinical improvement over ...