Judge Katsas Gregory G 's Rulings on Generic Drug Approval Standards

Vanda Pharmaceuticals, Inc. v. FDA

D.C. Circuit Vacates FDA's Rejection of Vanda's Hetlioz sNDA

Vanda Pharmaceuticals, Inc. v. FDA, decided by D.C. Circuit on August 15, 2025, resulted in a mixed outcome. The D.C. Circuit reviewed the FDA's refusal to approve Vanda Pharmaceuticals' supplemental ...