This article is more than 5 years old. Information may no longer be current.
Seven FDA news stories you may have missed
Click Here to Manage Email Alerts
In July, the FDA continued its string of 2018 endocrinology approvals. Endocrine Today has compiled a list of the past month’s approvals, updates and submissions as well as a study evaluating the effects of the FDA’s “breakthrough” designation on patient care.
FDA approves Azedra for rare adrenal gland tumors
The FDA approved iobenguane I 131 for adults and children with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require anticancer therapy.
Lilly submits NDA for nasal glucagon
Eli Lilly announced the submission of a new drug application to the FDA for investigational nasal glucagon for the treatment of severe hypoglycemia in adults and pediatric patients with diabetes.
FDA approves Orilissa to treat endometriosis pain
The FDA on Tuesday approved the first oral gonadotropin-releasing hormone antagonist indicated for women with moderate to severe endometriosis pain, AbbVie and Neurocrine Biosciences announced in a press release.
Dulaglutide label to reflect new safety, efficacy data in type 2 diabetes, CKD
Eli Lilly has updated the label for the once-weekly GLP-1 receptor agonist dulaglutide to reflect new safety and efficacy data reported for adults with type 2 diabetes and moderate to severe chronic kidney disease.
FDA approves 14-day FreeStyle Libre CGM sensor for diabetes
The FDA approved the FreeStyle Libre flash glucose monitoring system, which allows patients with diabetes to wear the sensor up to 14 days with high accuracy.
FDA clears first glucose meter for critically ill patients
The FDA has granted 510(k) clearance for the first finger-stick capillary testing meter for critically ill patients with and without diabetes.
FDA breakthrough therapy designation not associated with improved novelty, safety, efficacy
A “breakthrough” designation led to faster FDA approval for new medications, although these agents did not show improved safety, novelty or efficacy compared with nonbreakthrough agents, study data showed.