GC Biopharma announced on July 31st that its drug, 'GC5107B (immunoglobulin 10% for intravenous administration) is being reviewed in earnest by the U.S. Food and Drug Administration.

GC5107B is one of GC Biopharma’s blood derivative products that goes by the brand name Alyglo. The company had submitted a Biologics License Application (BLA) to the US FDA last month.

With FDA starting the review process in earnest, the company expects the results to come out by January next year.

The FDA assigned a target action date of January 13th (local time) next year, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision on 'GC5107B' will be made by then.