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BioWorld - Monday, December 2, 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 17, 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.
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Regulatory
Hematologic
BLA
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