News
FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs
NDA
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia
Clinical ResultPriority ReviewImmunotherapy
CervoMed Announces Last Patient Last Visit in Phase 2b RewinD-LB Trial of Neflamapimod for the Treatment of Early-Stage Dementia with Lewy Bodies (DLB)
Clinical Study
Immuneering Granted Orphan Drug Designation for IMM-1-104 by FDA in the Treatment of Pancreatic Cancer
Orphan DrugFast TrackClinical Result
GEn1E Lifesciences Publishes Breakthrough Research Unveiling Novel Mechanism of Action of Dual Signal Modulators for Anti-inflammatory and Endothelial-Stabilizing Therapies
Clinical Result
Pharming Group announces start of Phase II clinical trial of leniolisib for primary immunodeficiencies (PIDs) with immune dysregulation
ImmunotherapyClinical ResultDrug Approval
Jasper Therapeutics Reports Positive Data from SPOTLIGHT Study of Briquilimab in Chronic Inducible Urticaria
Clinical ResultImmunotherapyCell Therapy
INVO Bioscience and NAYA Biosciences Close Merger, Combined Company to Operate as NAYA Biosciences (NASDAQ: NAYA)
Executive ChangeAcquisition
Majority of children with spinal muscular atrophy (SMA) treated with Roche’s Evrysdi are able to sit, stand and walk independently, two-year data demonstrate
Clinical ResultOrphan DrugDrug Approval
NMPA Grants Marketing Approval to the First Co-Developed NGS-Based Companion Diagnostic for Lung Cancer in China
Clinical StudyDrug ApprovalClinical Result