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News about "European Medicines Agency (EMA"
FDA Grants Priority Review to Sonrotoclax to Treat Relapsed/Refractory Mantle Cell Lymphoma
The priority review positions sonrotoclax to potentially become the first BCL2 inhibitor approved in the U.S. for relapsed or refractory mantle cell lymphoma, offering a promising new option for patients with this aggressive and hard-to-treat cancer.
European Medicines Agency (EMA) | 28/11/2025 | By Dineshwori
Roche's Gazyva/Gazyvaro Shows Positive Results for Systemic Lupus Erythematosus in Phase III trials
The ALLEGORY study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva/Gazyvaro versus standard therapy.
European Medicines Agency (EMA) | 05/11/2025 | By Dineshwori | 137
European Commission approves EYLUXVI (ALT-L9) by Alteogen
EYLUXVI is the second biosimilar approved by the European Commission for Alteogen, following the launch of the Herceptin biosimilar in China through its partner Qilu Pharmaceutical.
European Medicines Agency (EMA) | 18/09/2025 | By Dineshwori
WuXi Biologics, a leading global contract research, development and manufacturing organisation (CRDMO), has announced that its Dundalk, Ireland facility has been approved by the European Medicines Agency (EMA) as a commercial manufacturing site for a client’s innovative biologic.
European Medicines Agency (EMA | 18/08/2025 | By Dineshwori | 171
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