Immunologic Factor
Shattuck Labs Shifts Focus to IBD Drug, Discontinues CD47 Program and Reduces Workforce by 40%
Shattuck Labs, CD47 program, workforce reduction, IBD drug, SL-325, DR3 antagonist antibody
FDA Tracker: Fresenius Kabi and Formycon’s Stelara Biosimilar Set for 2025 Launch
Stelara biosimilar, Fresenius Kabi, Formycon, FDA approval, ustekinumab, Johnson & Johnson, J&J settlements, biosimilar competition
Moderna Faces Second Consecutive Marketing Breach for Spikevax Vaccine
Moderna, Spikevax, Marketing Breach, COVID-19 Vaccine, Regulatory Compliance
Roche’s Gazyva Shows Promising Results in Phase 3 Lupus Nephritis Trial, Paving Way for Expanded Use
Gazyva, lupus nephritis, Roche, phase 3 trial, REGENCY study, obinutuzumab, kidney disease, autoimmune disease, treatment options.
Sanofi and Regeneron’s Dupixent Secures Historic FDA Approval as First Biologic Treatment for COPD
Dupixent, COPD, FDA Approval, Biologic Treatment, Sanofi, Regeneron
FDA Considers Restricting PD-1 Drugs in Stomach and Esophageal Cancers Based on PD-L1 Expression
PD-1 drugs, stomach cancer, esophageal cancer, PD-L1 expression, FDA restrictions, pembrolizumab, nivolumab, tislelizumab
FDA Advisory Panel Rejects PD-1 Inhibitors for Gastric and Esophageal Cancers with Low PD-L1 Expression
FDA, PD-1 inhibitors, gastric cancer, esophageal cancer, PD-L1 expression, biomarker, oncology, drug approval
Emergent BioSolutions Secures $400 Million in Orders for Smallpox and Mpox Vaccines Amid Ongoing Outbreak
Emergent BioSolutions, smallpox, mpox, vaccine orders, biodefense, global health preparedness
Amgen’s Mixed Results: A Tale of Two Readouts in Eczema and Myasthenia Gravis Trials
Amgen, Clinical Trials, Eczema, Myasthenia Gravis, Rocatinlimab, Uplizna, Biotechnology, Pharmaceutical Industry
Merck’s Keytruda and LAG-3 Antibody Combo Fails in Phase 3 Colorectal Cancer Trial
Keytruda, LAG-3, colorectal cancer, Phase 3 trial, Merck & Co., favezelimab, pembrolizumab, KEYFORM-007