Veozah is an oral neurokinin 3 (NK3) receptor antagonist.
Omnipod GO is a tubeless and waterproof insulin delivery system.
Tepezza is a human insulin-like growth factor-1 receptor inhibitor.
Novo Nordisk plans to file for regulatory approval of the 25mg and 50mg dosage strengths in 2023.
Evinacumab is a fully-human monoclonal antibody that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3).
The BLA is supported by data from the pivotal PULSAR and PHOTON trials.
The use of recalled products may lead to signs and symptoms of hypothyroidism.
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 approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients.
The approval was based on data from the phase 3b SUSTAIN FORTE trial, which compared Ozempic 2 mg to 1 mg in adults with type 2 diabetes.
The approval was based on data from the ORION-9, ORION-10, and ORION-11 trials that evaluated Leqvio in patients 18 years of age and older with HeFH or clinical ASCVD.
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 Mycapssa® (octreotide; Chiasma) capsules for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
The FDA has approved Gimoti™ (metoclopramide; Evoke Pharma) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
