A comprehensive view of CE Mark / Marketing Authorization (EU). This page highlights a small sample of our full coverage.
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European Medicines Agency delays decision on Biogen and Eisai's Alzheimer's drug lecanemab due to procedural implications from an EU court ruling; the delay is unrelated to the marketing authorization application submitted for lecanemab
Published:
March 26, 2024
by Zack's Commentary
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Abbott gets CE Mark approval for Bluetooth-enabled Assert-IQ insertable cardiac monitor in Europe; device offers the world's longest battery life and allows physicians to monitor patients' heart rhythms remotely for up to six years
Published:
March 25, 2024
by Abbott Laboratories
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Superbrewed Food receives FDA's GRAS status for its Postbiotic Cultured Protein, a bacteria-derived biomass ingredient, opening possibilities for food and beverage applications; company now prepares for market authorization in EU, UK and Canada
Published:
March 15, 2024
by ENP Newswire
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Roche unveils accuracy data for Accu-Chek SmartGuide, a real-time continuous glucose monitoring solution, at International Conference on Advanced Technologies and Treatments for Diabetes; solution awaits CE mark for launch in select European countries
Published:
March 07, 2024
by F. Hoffmann-La Roche Ltd. (Roche)
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