BreakBio Enters Clinic for Personalized Cancer Vaccine
Personalized cancer vaccine enters clinical testing as BreakBio joins Moderna and BioNTech in the emerging field, targeting low-mutational tumors.
ATG-201 Clears Australian Approval for Phase I Trial in B-Cell Autoimmune Diseases
ATG-201 clears Australian approval for Phase I trial in B-cell autoimmune diseases, advancing dual-market enrollment with UCB partnership.
Astellas Initiates Phase 3 Study of ASP2138 in CLDN18.2-Positive Gastric Cancer
Astellas initiates Phase 3 study of ASP2138, a bispecific T-cell engager, combined with chemotherapy and pembrolizumab in CLDN18.2-positive gastric...
FDA Approves IMAAVY (Nipocalimab) for Warm Autoimmune Hemolytic Anemia
FDA approves IMAAVY for warm autoimmune hemolytic anemia after Phase 2/3 trial showed three times higher durable hemoglobin response...
Sunshine Guojian Posts 95% Profit Growth With Two NMPA Drug Approvals
Sunshine Guojian posts 95% profit growth driven by two NMPA drug approvals for psoriasis and gouty arthritis in 2026.
FDA Approves Implantica’s RefluxStop for GERD Treatment
FDA approves Implantica's RefluxStop for GERD treatment based on five-year European data showing 90% improvement in symptom scores and...
Brii Biosciences Reports 42.9% HBsAg Loss With BRII-179 Combination in HBV Study
Brii Biosciences reports 42.9% HBsAg loss with BRII-179 combination in HBV study, significantly exceeding standard-of-care monotherapy results.
Akeso’s AK157D1 B7-H3 ADC Cleared for Phase I Trial in Solid Tumors
Akeso's AK157D1 B7-H3 ADC wins Phase I clearance in China for advanced solid tumors, targeting a protein overexpressed in...
FDA Clears PrecivityAD2 Blood Test for Alzheimer’s in Adults as Young as 40
FDA clears PrecivityAD2 blood test for Alzheimer's in adults as young as 40, expanding early detection and clinical trial...
Curavit Acquires Lindus Health CRO Assets to Expand U.S.-European Operations
Curavit acquires Lindus Health CRO assets to unify U.S.-European clinical trial operations and accelerate site activation across decentralized studies.