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November 28, 2023
Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022Marketing authorization was received for AVT04 in Canada and Japan, the first for a biosimilar to Stelara® (ustekinumab)The European Medicines Agency proposed market authorization for AVT04 in the 30 member states of the European Economic Area, pending a final decision by the European Commission Approvability of AVT02 and AVT04 in the U.S. now pending satisfactory US ...
November 27, 2023
LONDON - Vertex Pharmaceuticals today announced that the European Medicines Agency has validated a Type II variation application to the Marketing Authorization for KAFTRIO in combination with...
November 27, 2023
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for...
November 27, 2023
Belantamab mafodotin plus bortezomib and dexamethasone significantly improved progression-free survival compared with daratumumab plus B-Vd in the second-line treatment of patients with relapsed or refractory multiple myeloma, meeting the primary end point of the phase 3 DREAMM-7 trial.
November 24, 2023
-Application to add ~200 non-F508del CFTR mutations to the KAFTRIO® license- -If approved, ~2,800 people with cystic fibrosis in the European Union ages 2 and above could receive a medicine that...
November 22, 2023
/PRNewswire/ -- The "Global Recombinant DNA Technology Market Analysis & Forecast to 2023-2033: Market By Product; By End User; and By Region" report has been...
November 21, 2023
NexoBrid® commercially launched in U.S. and Japan; Company prioritizes operational resources to meet increased global demand EscharEx® Phase III study preparations progressing; Protocol...
November 21, 2023
NexoBrid® commercially launched in U.S. and Japan; Company prioritizes operational resources to meet increased global demand EscharEx® Phase III study...
November 21, 2023
Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European...