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Novo Nordisk s Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review - Novo Nordisk (NYSE:NVO)

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will review Novo Nordisk's application for once-weekly insulin icodec on May 24. Concerns include an increased risk of hypoglycemia in type 1 diabetes patients.

United statesNovo nordiskMetabolic drugs advisory committeeAmerican diabetes associationBiologics license applicationEuropean medicines agencyMedicinal productsHuman use

Novo Nordisk s Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review

Novo Nordisk s Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review
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Novo nordiskMetabolic drugs advisory committeeBiologics license application

FDA staff says Novo Nordisk s Awiqli has hypoglycemia risk

FDA staff says Novo Nordisk s Awiqli has hypoglycemia risk
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United statesEli lillyNovo nordiskAmerican diabetes associationMetabolic drugs advisory committeeDrug administrationEuropean medicines agencyAmerican diabetes

Will FDA Advisors Look Past Hypoglycemia Risk With Once-Weekly Insulin?

Hypoglycemia was only a concern in patients with type 1 diabetes

United statesNew yorkJulio rosenstockVelocity clinical research at medical cityNovo nordiskMetabolic drugs advisory committeeAmerican diabetes associationEuropean medicines agencyVelocity clinical researchMedical cityNew york city

Lilly s Once-Weekly Insulin Top-Line Results Show Benefit

Phase 3 data for efsitora alfa showed noninferiority to once-daily basal insulins in two studies of people with type 2 diabetes.

Los angelesEli lillyAnnel petersEuropean association for the study of diabetesDrug administration endocrinologicNovo nordiskUniversity of southern california westside centerMetabolic drugs advisory committeeDrug administrationMetabolic drugs advisoryAffordability areSouthern california westside centerMedscape medical newsData show noninferiorityDaily basalEuropean association

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