Orphan designation: resecabtagene autoleucel Treatment of systemic sclerosis, 21/11/2025 Positive

Orphan designation: soquelitinib Treatment of peripheral T-cell lymphoma, 20/10/2025 Positive

Orphan designation: bevantolol hydrochloride Treatment of Huntington's disease, 20/10/2025 Positive

Orphan designation: orziloben Treatment of intestinal failure-associated liver disease Positive

Orphan designation: aviptadil Treatment of acute respiratory distress syndrome (ARDS), 23/02/2026 Positive

Creon

Orphan designation: 1-{[2-(3,6-Diazabicyclo[3.1.1]heptan-3-yl)-7-(1,3-thiazol-2-yl)-1,3-benzoxazol-4-yl]oxy}-1,1-difluoro-2-methylpropan-2-ol Treatment of palmoplantar pustulosis Positive

PSUSA/00000415/202508

PSUSA/00000813/202508

Veterinary medicines European public assessment report (EPAR): Bluevac BTV (previously Bluevac BTV8), Status: Authorised