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News about "European Medicines Agency (EMA"
EMA Confirms Asundexian MAA for Assessment in Secondary Prevention of Ischemic Stroke
The EMA has accepted the Marketing Authorisation Application (MAA) for asundexian, the first Factor XIa (FXIa) inhibitor under review in Europe for secondary prevention of ischemic stroke. The submission is supported by positive phase 3 OCEANIC-STROKE data.
European Medicines Agency (EMA) | 11/06/2026 | By News Bureau | 110
EMA Recommends Approval of Jascayd for IPF and Progressive Pulmonary Fibrosis
Jascayd receives positive CHMP recommendation for approval in Europe to treat Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), addressing major unmet needs in severe and life-threatening lung diseases.
European Medicines Agency (EMA) | 25/05/2026 | By News Bureau | 122
US FDA Approves Wegovy by Novo Nordisk as first Oral GLP-1 for Weight Loss
Wegovy’s approval is supported by phase III OASIS 4 trial data showing a mean weight loss of 16.6 percent, with the oral GLP-1 indicated for long-term weight management and reduction of major adverse cardiovascular events, and Novo Nordisk planning a US launch in early January 2026.
European Medicines Agency (EMA) | 23/12/2025 | By News Bureau | 299
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 | 190
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 | 311
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 | 163
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 | 261
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