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RSS FeedPosted 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
Serplulimab approved in the EU for first-line treatment of extensive-stage small cell lung cancer
5 February 2025 - Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive stage small-cell lung ...
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
Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union (July 2024)
26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion on ...
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
CHMP recommends subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR mutated non-small cell lung cancer
3 February 2025 - Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic endpoints, ...
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 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 03 Feb 2025
Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer
3 February 2025 - Recommendation based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 31 Jan 2025
Datopotamab deruxtecan recommended for approval in the EU by CHMP for patients with previously treated metastatic HR positive, HER2 negative breast cancer
31 January 2025 - Recommendation based on TROPION-Breast01 results showing Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan reduced risk of disease ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma
31 January 2025 - Recommendation based on results of Phase 3 CheckMate-9DW clinical trial demonstrating statistically significant and clinically meaningful ...
Posted by Michael Wonder on 31 Jan 2025
Highlights from the 27-30 January 2025 CHMP meeting
31 January 2025 - Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the ...
Posted by Michael Wonder on 31 Jan 2025
Rystiggo (rozanolixizumab) for generalised myasthenia gravis receives EU approval for two new administration methods
31 January 2025 - Rystiggo can now be self-administered, or administered by a caregiver, with an infusion pump or manual push ...
Posted by Michael Wonder on 29 Jan 2025
EMA publishes agenda for 27-30 January 2025 CHMP meeting
27 January 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...