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VCN Biosciences’ VCN-01 Receives FDA Designation

VCN Biosciences’ VCN-01 Receives FDA Designation

Feb 9, 2022 | FDA, News, Regulatory

Synthetic Biologics has announced that VCN Biosciences has received an Orphan Drug Designation from the US Food and Drug Administration (FDA) for their therapy, VCN-01, to treat retinoblastoma. Retinoblastoma is a rare cancer of the eye that develops from immature...
ALX Oncology: Evorpacept Receives ODD to Treat GC

ALX Oncology: Evorpacept Receives ODD to Treat GC

Jan 28, 2022 | FDA, News, Regulatory

The U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) for ALX Oncology’s evorpacept, a next-generation CD47 blocker, to treat patients with gastric cancer and gastroesophageal junction cancer. Gastric cancer and gastroesophageal...
FDA Grants Second Approval for Gilead’s Trodelvy

FDA Grants Second Approval for Gilead’s Trodelvy

Apr 14, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) granted accelerated approval for Trodelvy, a drug therapy for patients with locally advanced or metastatic urothelial cancer (mUC), an aggressive disease with a survival rate of 5.5%. Previously, Trodelvy was granted...