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Orphan DrugFast TrackClinical Study
License out/inDrug Approval
22 May 2026
Dechra Announces FDA Approval of CosACTHen® (cosyntropin injection), the First and Only Cosyntropin Approved Specifically for Canine Patients
Drug Approval
22 May 2026
BioLineRx and Hemispherian Announce New GLIX1 Data Demonstrating Potent Anti-Tumor Effect in Glioblastoma (GBM) Across Multiple In-Vivo Studies, Including a Temozolomide (TMZ)-Resistant Model with Patient-Derived Xenografts
Clinical Study
21 May 2026
MEKanistic Therapeutics Announces FDA Clearance of IND for MTX-531, Enabling Phase 1 Trial in Advanced Solid Tumors
IND
21 May 2026
Cell TherapyOrphan Drug
21 May 2026
Vertero Advances into Phase 1b Study with VT-5006 for the Treatment of Parkinson’s Disease
Enlivex Announces Dosing Of First Patient In The United States As Part Of Its Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis
IND
21 May 2026
FDA Grants Breakthrough Therapy Designation to VERTANICAL's VER-01, a First-in-Class Non-Opioid Investigational Treatment for Chronic Low Back Pain
Clinical ResultBreakthrough Therapy