Semaglutide Superior to Liraglutide for Weight Loss
Findings reported for subcutaneous treatment in overweight, obese adults also using diet, physical activity
Metabolic Disorders
FDA Rejects Intranasal Carbetocin NDA for Prader-Willi Syndrome
LV-101 is an investigational intranasal formulation of carbetocin, an analogue of oxytocin.
Long-Term Medication Usage After Bariatric Surgeries Compared
Patterns of medication use for obesity-related comorbidities slightly more favorable following gastric bypass versus sleeve gastrectomy
FDA Extends Review Period for Gene Therapies for Beta-Thalassemia, Cerebral Adrenoleukodystrophy
The FDA extended the target dates for beti-cel and eli-cel to allow time to review additional clinical information for both applications.
FDA Requests Clinical Outcomes Data for Galactosemia Treatment
Galactosemia is a rare genetic metabolic disease caused by an inability to metabolize galactose.
Generic Version of Carbaglu Now Available
Carglumic acid is a carbamoyl phosphate synthetase 1 activator.
Weight Loss Medication Wegovy in Short Supply
A contract manufacturer who fills the single-dose prefilled syringe pens has stopped deliveries following issues with Good Manufacturing Practices.
Gene Therapy Gets Priority Review for Cerebral Adrenoleukodystrophy
Elivaldogene autotemcel (eli-cel) is a one-time gene therapy designed to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells, resulting in the production of ALDP.
Enzastaurin Gets Orphan Drug Status for Vascular Ehlers-Danlos Syndrome
Vascular EDS is the most severe subtype of Ehlers-Danlos syndrome.
Sulfur Microbial Diet May Increase Risk for Colorectal Cancer
Sulfur microbial diet features high intakes of low-calorie drinks, red meats, processed meats and low intakes of fruits, vegetables, whole grains
