FDA Approves New Combination Therapy for Type 2 Diabetes
The FDA has approved Qternmet XR (AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
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Alirocumab Approved to Reduce Risk for Serious Cardiovascular Events
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.
FDA Approves Novel Nonsurgical Device for Weight Loss in Obese Patients
The device, which is approved for 12 months of treatment, is approximately 5.6cm in diameter and is delivered and retrieved endoscopically.
FDA Approves First-in-Class Sclerostin-Inhibitor for Postmenopausal Women at High Risk for Fracture
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.
FDA Rejects NDA for Gastroparesis Treatment Gimoti
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).
Treatments for Preventing Fracture in Postmenopausal Women Compared
Overall, treatments that were associated with the greatest relative risk reduction in fragility fractures included teriparatide, abaloparatide, denosumab, romosozumab and most bisphosphonate.
Semaglutide Plus SGLT2 Inhibitor Therapy Improves Glycemic Control in T2D
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.
Soliqua 100/33 Indication Expanded to Include T2D Patients Uncontrolled on Oral Antidiabetic Agents
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.
Liquid Levothyroxine Formulation Now Available to Treat Hypothyroidism
Tirosint-SOL (levothyroxine sodium oral solution) has been made available by IBSA Pharma for the treatment of hypothyroidism and pituitary thyrotropin suppression.
Farxiga, Xigduo XR Labeling Updated to Include Use in T2D Patients With Moderate Renal Impairment
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.
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