Tag: Drug Approvals
Approved-Label Populations for New Drugs Broader Than Trial Populations
Inconsistency seen most often in terms of patient fitness, with variance in almost all approved indications
Kerendia Approved for Heart Failure With Left Ventricular Ejection Fraction ≥40 Percent
Patients taking Kerendia saw significant reduction in cardiovascular death and hospitalization and urgent visits for heart failure
FDA Publishes Full Texts of Response Letters to Drug Applications
The goal is to improve public understanding of the FDA decision-making process
FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis
Benlysta is the first and only approved autoinjector biologic for both systemic lupus erythematosus and lupus nephritis
FDA Approves Dupixent for Bullous Pemphigoid
Benefits include sustained disease remission, reductions in itch, lower oral corticosteroids dose
FDA Approves Monjuvi for Relapsed, Refractory Follicular Lymphoma
Significantly improved progression-free survival seen with Monjuvi in combination with rituximab and lenalidomide
FDA Approves Twice-Yearly Yeztugo for Preexposure Prophylaxis to Cut HIV Risk
Approval marks first and only twice-yearly option available in the United States for PrEP
FDA Approves Once-Monthly Andembry for Hereditary Angioedema
The monoclonal antibody is a self-administered injection for prophylactic use to prevent attacks
FDA Offers Speedier Approvals to Drug Companies Aligning With ‘National Priorities’
Agency is offering vouchers to some drug manufacturers to shorten review time for final drug applications
