The FDA has approved Oriahnn™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules; AbbVie) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Specifically, unacceptable levels of this potentially carcinogenic impurity have been identified in products manufactured by 5 different firms.
The FDA has accepted for review the New Drug Application for dasiglucagon HypoPal® Rescue Pen (Zealand Pharma) for the treatment of severe hypoglycemia.
The FDA has updated its “Problems Reported with Essure” webpage to include medical device reports received in 2019.
The FDA has approved Fensolvi (leuprolide acetate; Tolmar Pharmaceuticals) for the treatment of pediatric patients 2 years of age and older with central precocious puberty.
Post-approval study results on the risk of hyperinflation, acute pancreatitis, and death associated with the use of liquid-filled intragastric balloons have been made available by the FDA.
The FDA has launched a new webpage with information for recovered individuals who were infected with coronavirus disease 2019 (COVID-19) on where they can go to donate plasma to aid in the treatment of severely ill patients.
The FDA has granted Orphan Drug designation to TransCon hGH (lonapegsomatropin; Ascendis Pharma), a long-acting prodrug of somatropin, for the treatment for growth hormone deficiency.
Serological tests allow for identification of individuals who have overcome COVID-19 infection.
Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver.
