June endocrine drug approvals: new insulins, rare bone disease drug and more
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In June, the FDA approved burosumab for a second rare bone disease, expanded the indication for an interoperable insulin pump, cleared an integrated continuous glucose monitor, and approved a biosimilar and a new faster-acting insulin.
FDA approves burosumab for tumor-induced osteomalacia
The FDA approved burosumab-twza injection to treat patients aged 2 years and older with tumor-induced osteomalacia, according to an agency press release. READ MORE
FDA clears next-generation integrated continuous glucose monitor
The FDA has cleared a next-generation integrated continuous glucose monitoring system for adults and children aged 4 years and older with diabetes, according to a press release from Abbott. READ MORE
FDA clears interoperable insulin pump for pediatric use
The FDA cleared an expanded pediatric indication for the t:slim X2 interoperable insulin pump, lowering its indicated age for use in children from age 14 years to age 6 years, according to a press release from Tandem. READ MORE
FDA approves biosimilar insulin glargine
The FDA approved a new drug application for Semglee, a biosimilar to insulin glargine, in vial and prefilled pens for children and adults with type 1 diabetes and adults with type 2 diabetes, according to a press release from Mylan and Biocon. READ MORE
FDA approves novel, faster-acting insulin lispro injection
The FDA approved Lyumjev, a novel, faster-acting insulin lispro injection, to improve glycemic response in adults with type 1 and type 2 diabetes, according to a press release from Eli Lilly. READ MORE
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