The approval was based on data from a clinical program that included 23 clinical trials enrolling more than 5000 adults with type 2 diabetes mellitus.
Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
The trial evaluated the efficacy and safety of empagliflozin and linagliptin in 175 patients 10 to less than 18 years of age with type 2 diabetes.
Evinacumab is a fully-human monoclonal antibody that binds to and blocks the function of angiopoietin-like 3.
Tzield is anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
These dietary supplements have not been evaluated by the FDA for safety or effectiveness.
Rezvoglar may now be substituted for Lantus at the pharmacy counter without the need for an intervention from the prescriber.
TransCon PTH is an investigational once-daily long-acting prodrug of parathyroid hormone (PTH[1-34]) designed to restore physiologic levels of PTH for 24 hours each day.
The multicenter, randomized, controlled GRADE study was designed to compare the effectiveness of 4 major FDA-approved medications.
The product should be stored in a refrigerator but can be kept at room temperature for up to 12 months.
The 68-week STEP 3 trial compared the efficacy and safety of semaglutide, a glucagon-like peptide 1 receptor agonist, to placebo plus IBT.
The effect of empagliflozin on all-cause mortality and hospitalization for heart failure will be evaluated in the in phase 3 EMPACT-MI study.
The multicenter, double-blind, placebo-controlled HAUSER-RCT study assessed the efficacy and safety of evolocumab in 157 patients aged 10 to 17 years with HeFH.
The FDA concluded “the risk no longer meets the standard for a Boxed Warning.”
EyeArt is the first FDA-cleared AI technology for autonomous detection of more than mild diabetic retinopathy and vision-threatening diabetic retinopathy.
The FDA has approved Qutenza® (capsaicin 8% patch; Averitas Pharma) for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet.
Xeris Pharmaceuticals announced the launch of Gvoke HypoPen™ (glucagon) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 2 years and older.
The FDA has approved Gimoti™ (metoclopramide; Evoke Pharma) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
The FDA has approved Lyumjev™ (insulin lispro-aabc injection; Lilly) to improve glycemic control in adults with type 1 and type 2 diabetes.
The FDA has approved Semglee™ (insulin glargine injection; Mylan and Biocon) to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Lilly announced the availability of lower-priced, non-branded versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®.
Novo Nordisk has launched its Diabetes Patient Assistance Program in response to the COVID-19 pandemic for patients with diabetes who have lost health insurance coverage due to a change in job status.
The submission is supported by three phase 3 trials in adult and pediatric patients that showed dasiglucagon met the primary and all key secondary end points.
Lilly announced the launch of its Insulin Value Program to assist patients with or without commercial insurance with filling their monthly insulin prescriptions for $35.
Companion Medical announced that it has received clearance from the Food and Drug Administration (FDA) for a new bolus calculator for fixed dosing and meal estimation to be used with the InPen system.
Medtronic is recalling certain MiniMed 600 Series insulin pumps due to a missing or broken retainer ring that can potentially lead to the under or over delivery of insulin.
Fresenius Kabi announced the launch of Glucagon Emergency Kit for the treatment of severe hypoglycemic episodes in adult and pediatric patients with diabetes.
To date, the FDA has not recommended a recall of metformin products in the US due to the relatively low levels of NDMA found in these products.
A Prescription Drug User Fee Act (PDUFA) target date of July 13, 2020 has been assigned to the application.
