D.C. Circuit: FDA Erred In Denying Drug Application Without Holding Hearing

( August 19, 2025, 11:06 AM EDT) -- WASHINGTON, D.C. — The U.S. Food and Drug Administration erred in refusing to hold a hearing before denying Vanda Pharmaceuticals Inc.’s application for approval to market the drug tasimelteon as a treatment for jet lag, the District of Columbia Circuit U.S. Court of Appeals said....