Last edition
News about "Marketing Authorisation Application (MAA)"
US FDA Accepts NDA under Priority Review for Takeda's Zasocitinib
The US Food and Drug Administration (FDA) has accepted Takeda’s New Drug Application (NDA) for zasocitinib under Priority Review (PR) for the treatment of moderate-to-severe plaque psoriasis, potentially redefining expectations for oral treatment.
Marketing Authorisation Application (MAA) | 15/09/2026 | By News Bureau
Fresenius Wins US FDA and EMA Review Acceptance for Vedolizumab Biosimilar
Fresenius has secured US Food and Drug Administration (FDA) and European Medicines Agency (EMA) review acceptance for its vedolizumab biosimilar, targeting Ulcerative Colitis (UC) and Crohn's Disease (CD) in adults.
Marketing Authorisation Application (MAA) | 03/08/2026 | By News Bureau | 578
EMA Fast-Tracks Review of New Metastatic Pancreatic Cancer Drug
The European Medicines Agency (EMA) has initiated a phased review of a new medicine for metastatic pancreatic cancer, accelerating its assessment to address a significant unmet medical need.
Marketing Authorisation Application (MAA) | 09/07/2026 | By News Bureau | 123
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 | 229
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 | 175
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 | 296
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy