News
Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104
NDAClinical ResultOrphan Drug
ADC
Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer’s Disease and Dementia with Lewy Bodies (DLB)
Breakthrough Therapy
FDA Grants Orphan Drug Designation to Medicovestor’s First-in-Class ADC for Pancreatic Cancer
ImmunotherapyOrphan DrugADC
Actimed Therapeutics Enrolls First Patients in Phase 2a PROACT Study Programme to Assess S-pindolol benzoate in Obese Patients During and Post-GLP-1 Agonist Therapy
Orphan Drug
Biodexa Announces Activation of First Clinical Study Site for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)
Fast TrackDrug Approval
20 Jun 2025
Diagonal’s First-in-Class Clustering Antibody, DIAG723, Receives Orphan Drug Designation (ODD) from U.S. FDA and an ODD Positive Opinion from EMA for Treatment of Hereditary Hemorrhagic Telangiectasia (HHT)
Orphan Drug