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News  ›  GlobeNewswire Inc.

Alvotech birtir nýjar upplýsingar um stöðu umsóknar um markaðsleyfi fyrir AVT05 í Bandaríkjunum

GlobeNewswire Inc. Logo GlobeNewswire Inc. By Benedikt Stefánsson
Alvotech birtir nýjar upplýsingar um stöðu umsóknar um markaðsleyfi fyrir AVT05 í Bandaríkjunum

Alvotech announced that the FDA will not approve its AVT05 biologics license application until manufacturing facility issues are resolved. The company expects lower 2025 revenues and will work to address FDA's concerns.

Insights
ALVO   negative

FDA delayed markeT approval for AVT05, requiring manufacturing facility improvements, which will reduce projected 2025 revenues and temporarily slow production