FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved ...
Genialis Expressions empowers drug development teams to make confident decisions by unifying workflows and standardizing omics data for enterprise-grade clarity and comparability across studiesBOSTON ...
The regulatory landscape for biosimilars is undergoing significant change on both sides of the Atlantic. Recent developments signal a potential shift away from the requirement for a clinical efficacy ...
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