The prefilled syringe requires fewer preparation steps than the vial.
Ezallor Sprinkle is intended for patients who have difficulty swallowing.
Dapagliflozin was recently approved for T1D in Europe and Japan.
The FDA has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization in patients with chronic heart failure.
The approval of Victoza in this patient population was based on data from the ELLIPSE trial which included 134 children and adolescents.
Slynd contains drospirenone, a spironolactone analogue.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Vascepa (icosapent ethyl; Amarin) to reduce residual cardiovascular.
The National Lipid Association (NLA) has released updated guidance for clinicians on identifying patients for which proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor therapy would provide reasonable value. Currently, two PCSK9 therapies have been approved by the Food and Drug Administration. Alirocumab is indicated as an adjunct to diet, alone or in combination with…
The Food and Drug Administration (FDA) has approved Eylea (aflibercept; Regeneron) for the treatment of diabetic retinopathy.
The FDA has approved Qternmet XR (AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
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.
Topline data from the Phase 3 STELLAR-4 trial showed that selonsertib, an investigational treatment for patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), was not associated with a significant improvement in fibrosis without worsening of NASH.
Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.
To investigate the association between this diabetes drug class and IBD risk, the study authors searched various databases for controlled clinical trials and observational studies involving DPP-4 inhibitors where IBD events were reported.
In the Biologics License Application (BLA) resubmission, Amgen and UCB proposed to narrow the indication to treatment of osteoporosis in postmenopausal women at high risk of fracture.
The FDA takes the advice of the panel into consideration when making decisions, however it is not bound by their recommendations.
An expert panel assessed 41 diets to come up with their final results, examining the evidence behind each diet’s claims, the short-term and long-term weight loss associated with the diet, how easy the diet is to follow, how well each diet conforms to current nutrition standards, and its effect on diabetes and cardiovascular disease prevention.
For this study, the authors identified randomized controlled trials (RCTs) that compared SGLT2 inhibitors with placebo, no treatment, or another antidiabetic agent and reported on UTI outcome.
To investigate the association between hormone therapy and carpal tunnel syndrome risk, researchers conducted a secondary analysis of the Women’s Health Initiative (WHI) hormone therapy trials.
Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity.
“This is the first report of decreased insulin requirements in a patient with [T1D] correlating with micafungin administration,” noted the authors.
