The FDA has approved Qternmet XR (AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
All articles by Diana Ernst, RPh
The FDA has approved Praluent (alirocumab; Sanofi and Regeneron), a PCSK9 inhibitor, to reduce the risk of myocardial infarction (MI), stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
The device, which is approved for 12 months of treatment, is approximately 5.6cm in diameter and is delivered and retrieved endoscopically.
The Food and Drug Administration (FDA) has approved Evenity (romosozumab-aqqg; Amgen) injection for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapies.
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Evoke Pharma regarding the New Drug Application (NDA) for Gimoti (metoclopramide nasal spray).
Overall, treatments that were associated with the greatest relative risk reduction in fragility fractures included teriparatide, abaloparatide, denosumab, romosozumab and most bisphosphonate.
According to results from the SUSTAIN trial, the addition of semaglutide, a glucagon-like peptide-1 receptor agonist, to a sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy led to significant improvements in glycemic control, as well as weight reduction, in patients with inadequately controlled type 2 diabetes.
The Food and Drug Administration (FDA) has approved an expanded indication for Soliqua 100/33 to include use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are uncontrolled on oral antidiabetic agents, in addition to those inadequately controlled on basal insulin or lixisenatide.
Tirosint-SOL (levothyroxine sodium oral solution) has been made available by IBSA Pharma for the treatment of hypothyroidism and pituitary thyrotropin suppression.
The Food and Drug Administration (FDA) has approved updated labeling for Farxiga (dapagliflozin; AstraZeneca) and Xigduo XR (dapagliflozin and metformin HCl extended-release; AstraZeneca) to expand the use of these products in type 2 diabetes patients with moderate renal impairment.