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News about "Marketing Authorisation Application (MAA)"
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.
Marketing Authorisation Application (MAA) | 11/06/2026 | By News Bureau | 110
IntraBio Submits EMA Variation Application for AQNEURSA in Ataxia-Telangiectasia
IntraBio has submitted a variation application to the European Medicines Agency (EMA) for AQNEURSA as a treatment for Ataxia-Telangiectasia. If approved, it would become the first authorised therapy for this disorder in the European Economic Area.
Marketing Authorisation Application (MAA) | 06/06/2026 | By News Bureau
Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab
Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).
Marketing Authorisation Application (MAA) | 24/09/2025 | By Dineshwori | 194
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