orphan drug designation

Tokyo, August 26, 2026 Daiichi Sankyo announced that the first patient has been dosed in TROPION-Urothelial04, a global Phase...

BOCA RATON, Fla., Aug. 26, 2026 INmune Bio Inc. has advanced Ebstrocel™ toward potential European commercialization after submitting two...

MECHELEN, Belgium — August 24, 2026 Lakefront Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has granted...

Washington, D.C., August 24, 2026 Vanda Pharmaceuticals Inc. announced that the European Commission has granted Orphan Designation to imsidolimab...

MELBOURNE, Australia, August 6, 2026 Propanc Biopharma announced compelling preclinical and early translational findings for its lead investigational therapy...

Taiwan, August 6, 2026 Senhwa Biosciences, Inc. has received Taiwan Food and Drug Administration (TFDA) clearance for a multicenter...

Boston, Massachusetts, August 5, 2026 Galibra Neuroscience has received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation...

Brooklyn, New York, August 5, 2026 Phoenix Nest Inc. has been awarded a $2,984,658 Small Business Innovation Research (SBIR)...

BOSTON, Aug. 3, 2026 Zevra Therapeutics, Inc. announced the publication of four-year real-world safety and effectiveness data evaluating MIPLYFFA®...

CRANBURY, N.J., Aug. 3, 2026 Rocket Pharmaceuticals, Inc. announced a positive clinical safety update from the first three patients...