AstraZeneca ($AZN) announced an update on their ongoing clinical study. AstraZeneca recently completed a clinical study titled ‘A Multiple Centre, ...
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 ...
PE: How are global regulatory agencies adjusting their policies for biosimilars? Woollett: The clear leaders in the space of biosimilar development have been the European agency, the UK, and US FDA.