Orphan drug designation (ODD) for “treatment of stage IIb-IV melanoma” by FDA
As of May 1, 2020, NewG Lab Pharma received a letter from the FDA for Orphan drug designation (ODD) for “treatment of stage IIb-IV melanoma”.
As a result, NewG Lab Pharma acquired Orphan drug status for liver cancer, intra-hepatic bile duct cancer and melanoma.
NewG Lab Pharma plans to start the FDA Phase 1 clinical trial in 2021.
Orphan drug designation (ODD) for “treatment of stage IIb-IV melanoma” by FDA