FDA Clears FreeStyle Libre 2 App to Monitor Glucose Levels
By scanning the glucose sensor with the app, users will be able to receive their current glucose level, trend arrow, and glucose history.
Endocrine Disorders
Semglee Approved as First Interchangeable Biosimilar Insulin Product
Semglee (insulin glargine) may be substituted for the reference product, Lantus, at the pharmacy counter and without the intervention of the prescriber.
FDA Approves Spinal Cord Stimulation Therapy for Painful Diabetic Neuropathy
Nevro’s SCS system for painful diabetic neuropathy will be available under the brand name HFX™ for PDN.
Kerendia Approved to Reduce CKD Progression, CV Risk in Patients With Diabetic Kidney Disease
The approval was based on data from the phase 3 FIDELIO-DKD trial.
FDA Panel Votes on Teplizumab for the Delay of Type 1 Diabetes
Teplizumab is an investigational anti-CD3 monoclonal antibody.
Investigational Gene Therapy Fast Tracked for Congenital Adrenal Hyperplasia
BBP-631 is an adeno-associated virus 5 (AAV5) gene therapy designed to deliver a functional copy of the 21-hydroxylase gene to restore the body’s ability to produce cortisol and aldosterone.
Levoketoconazole Under Review for Endogenous Cushing Syndrome
The NDA submission includes data from the phase 3 SONICS and LOGICS studies that evaluated levoketoconazole in adults with endogenous Cushing syndrome.
Black Cohosh Appears Safe, but May Not Benefit Women With PCOS-Related Infertility
Black cohosh is a natural phytoestrogen product occasionally used in the management of PCOS-related infertility.
Insulin Product Samples Recalled Due to Improper Storage Temperature Conditions
The product samples are being recalled because they were stored at temperatures below storage requirements.
FDA Clears Insulin Dose Decision Support System With Smart Pen Caps
The Bigfoot Unity System uses iCGM data from Abbott’s FreeStyle Libre 2 system and consists of smart pen caps for rapid- and long-acting insulin, as well as a mobile app.
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