orphan drug designation

MONTEREY, California, USA, April 28, 2026 BRC Therapeutics has announced that the U.S. Food and Drug Administration has cleared...

Sydney, Australia | April 15, 2026 Immutep Limited has achieved a significant regulatory milestone with the U.S. Food and...

SHANGHAI, China, March 31, 2026 Abbisko Therapeutics has announced that its investigational FGFR4 inhibitor irpagratinib (ABSK-011) has been granted...

Ashburn, Virginia — March 9, 2026 Clinical-stage specialty biopharmaceutical company Quoin Pharmaceuticals Ltd. continues to advance the development of...

Paris, March 2, 2026 Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug...

Shelton, Connecticut — February 10, 2026: NanoViricides, Inc., a clinical-stage antiviral nanomedicine company, announced the filing of an Orphan...

WALTHAM, Mass., Feb. 2026 — Partner Therapeutics announced that zenocutuzumab-zbco, an investigational bispecific antibody therapy, has received U.S. FDA...

Toronto, Ontario, January 16, 2026 — Cardiol Therapeutics announced a bought deal private placement financing for gross proceeds of...

Toronto, Jan. 13, 2026 — Cardiol Therapeutics Inc. announced that it has surpassed the 50% patient enrollment milestone in...

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