A new study published in Therapeutic Innovation & Regulatory Science provides crucial insights into the design and ...

FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studies FDA provides clear guidance on approvability expectations for pharmacokinetic (PK) performance ...

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 ...

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 ...

Genialis Expressions empowers drug development teams to make confident decisions by unifying workflows and standardizing ...