Inclisiran Approval Held Up by Inspection-Related Issues
Inclisiran is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA.
Inclisiran is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA.
As both the vaccine and Tepezza are being manufactured at Catalent, the government has prioritized the manufacturing of the vaccine thereby resulting in cancellation of previously contracted Tepezza orders.
The alert was based on data from three 20-week double-blind, placebo-controlled studies each with 34-week extensions.
The long-acting human insulin analogue has an identical amino acid sequence to Lantus® (insulin glargine; Sanofi).
Influenza vaccination should occur by the end of October, if possible.
Hand sanitizers containing methanol, or wood alcohol, present a danger to individuals as the substance can be toxic when absorbed through the skin or life-threatening if ingested.
The FDA has approved the FreeStyle® Libre 2 integrated continuous glucose monitoring system (Abbott) for adults and children ≥4 years of age with diabetes.
Nexlizet (bempedoic acid and ezetimibe; Esperion) is now available for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
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.