Amgen’s dazodalibep has met the primary endpoint in the Phase 3 OASIZ 301 study, improving systemic Sjögren’s disease activity as early as Week 4 and sustaining the benefit through Week 48. The result is a major step in a disease with no FDA-approved systemic treatment specifically for Sjögren’s, but Amgen has not yet disclosed the
Remibrutinib beat teriflunomide on relapse rates and every key secondary endpoint across the Phase 3 REMODEL studies, while avoiding the liver-safety signal that has complicated development of other BTK inhibitors.
Novartis and Ionis say pelacarsen substantially reduced lipoprotein(a) but failed to reduce major cardiovascular events in the 8,323-patient Phase 3 Lp(a)HORIZON trial.
Remibrutinib wins two Phase III multiple sclerosis trials as Novartis prepares global filings. See what the results mean for the BTK race.
Novartis says oral BTK inhibitor remibrutinib significantly reduced relapse rates and MRI lesions versus teriflunomide in both Phase 3 REMODEL trials, with no liver safety signal and global regulatory filings now planned.
Aurisco’s FDA inspection for inclisiran sodium puts generic oligonucleotide manufacturing closer to a crucial regulatory and commercial test.
Fate Therapeutics has treated the first participant in RECLAIM-LN, a Phase 2 study evaluating its off-the-shelf CD19-directed CAR T-cell candidate FT819 in people with refractory moderate-to-severe lupus nephritis. The company disclosed the trial initiation on August 14, 2026, saying the first participant received FT819 in an outpatient setting and was discharged on the same day.
The United States Food and Drug Administration (FDA) has approved Novartis Pharmaceuticals Corporation’s Pluvicto in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer, moving targeted radioligand therapy into an earlier stage of the disease. The July 31 approval covers patients whose metastatic cancer remains responsive
Nuvectis Pharma’s ciprocopan wins China approval for PNH. Read how the once-daily Factor B drug could reshape the global treatment race.
Novartis is acquiring Myricx Bio for up to $1.5 billion to gain control of a new NMT inhibitor payload platform, but the lead antibody-drug conjugates have not yet entered human trials.