In early March 2026, the U.S. Food and Drug Administration (FDA) issued updates to its Q&A guidance interpreting and implementing the Biologics ...

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 FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...