Vanda Urges FDA to Reject Extended Drug Review Timelines
WASHINGTON, April 9, 2026 Vanda Pharmaceuticals Inc. has publicly called on the U.S. Food and Drug Administration (FDA) to...
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BioXcel IGALMI sNDA Accepted by FDA for At-Home Use
NEW HAVEN, Conn., USA — April 1, 2026 BioXcel Therapeutics, Inc. announced that the U.S. Food and Drug Administration...
FDA Advances Tradipitant Review for Motion Sickness Relief
Washington, D.C., November 28, 2025 In a significant regulatory development, Vanda Pharmaceuticals Inc. has announced major progress on tradipitant,...
Unicycive Therapeutics to Resubmit OLC NDA After FDA Type A Meeting
Los Altos, California, October 28, 2025 — Unicycive Therapeutics, Inc., a clinical-stage biopharmaceutical company developing treatments for kidney disease,...
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