Pre-NDA meeting

BEDFORD, Mass. — September 15, 2026 Ocular Therapeutix, Inc. announced the successful completion of its Pre-New Drug Application (Pre-NDA)...

San Diego, California, July 27, 2026 Gossamer Bio, Inc. announced a series of significant regulatory, strategic, and financial milestones...

NEW YORK | December 31, 2025 — Axsome Therapeutics announced it has received formal FDA pre–New Drug Application (Pre-NDA)...