Vanda Pharmaceuticals, Inc. v. FDA
D.C. Circuit Reverses FDA's Rejection of Vanda's Hetlioz sNDA for Pediatric Use
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 ...