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BioWorld - Sunday, April 28, 2024
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» After FDA rejection, GC Biopharma refiles Alyglo’s BLA
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After FDA rejection, GC Biopharma refiles Alyglo’s BLA
July 18, 2023
By
Marian (YoonJee) Chu
No Comments
GC Biopharma Corp., formerly Green Cross Corp., said July 17 that it refiled the BLA for its intravenous immune globulin agent Alyglo (GC-5107B; IVIG-SN 10%) to the U.S. FDA – nearly a year and a half after the regulator’s initial rejection.
BioWorld Asia
Regulatory
Hematologic
BLA
FDA