The U.S. Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj), a Novolog (insulin aspart) biosimilar, for the control of glycemia in adults and pediatric patients with diabetes mellitus. Merilog is the first FDA-approved rapid-acting insulin biosimilar and is available as a 3 mL prefilled pen and a 10 mL multiple-dose vial. Merilog reduces mealtime blood sugar surges, allowing for improved control of diabetes.
The American Association of Clinical Endocrinology (AACE) has introduced a new guideline for managing dyslipidemia, which refers to abnormal cholesterol levels. This guideline provides evidence-based recommendations for newer drug therapies and emphasizes patient-centered outcomes, particularly the reduction of cardiovascular disease (CVD) risk. It is intended for adults aged 18 and older who have dyslipidemia or high triglycerides and are already receiving standard treatment but may need additional medications.
The U.S. Food and Drug Administration (FDA) has given the green light to a new combination therapy for adults suffering from specific types of relapsed or hard-to-treat large B-cell lymphomas (LBCL) who are not suitable candidates for stem cell transplants or CAR-T therapy. This innovative treatment consists of brentuximab vedotin (Adcetris), lenalidomide, and rituximab (BV+R2). It specifically targets types of LBCL such as diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL that arises from slower-growing lymphoma.
The U.S. Food and Drug Administration (FDA) has approved a new treatment regimen that includes Pfizer’s ADCETRIS® (brentuximab vedotin) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This is an important development as it provides a new option for individuals who have not responded to at least two previous therapies and are not candidates for more aggressive treatments such as stem cell transplantation or CAR T-cell therapy.
The US FDA has approved a new expanded label for Astellas Pharma’s IZERVAY™ (avacincaptad pegol intravitreal solution) to treat geographic atrophy (GA) due to age-related macular degeneration (AMD) long-term. The expansion provides physicians and patients with more options for treating this progressive and chronic eye disease, which can cause irreversible vision loss.