April 14 (ZFJ) — The Food and Drug Administration cleared the Dexcom Stelo Glucose Biosensor System, the first continuous glucose monitor (CGM) approved for use without a prescription in America, for marketing on March 5.
Stelo is an integrated CGM (iCGM) intended for anyone 18 years and older who doesn’t use insulin, such as diabetic individuals treating their condition with oral medications or people without diabetes who want to see how diet and exercise impact their blood sugar levels.
Dec. 30 (ZFJ) — The U.S. Food and Drug Administration approved two cell-based gene therapies, Casgevy and Lyfgenia, to treat sickle cell disease in patients 12 years and older, the agency announced on Dec. 8, 2023. Casgevy is the first FDA-approved treatment to use CRISPR/Cas9 gene-editing technology.
Sickle cell disease is a group of inherited blood disorders. It affects about 100,000 Americans, is most common in African Americans, and also affects Hispanic Americans.
July 16 (ZFJ) — The World Health Organization’s cancer research agency categorized non-sugar sweetener aspartame as “possibly carcinogenic to humans” (group 2B) based on “limited evidence” for causing cancer in humans on Friday, July 14. A WHO joint panel did not change its acceptable daily limit of 40 mg/kg body weight.
Aspartame is an artificial sweetener that has been widely used in foods and beverages since the 1980s as an alternative to sugar.
July 12 (ZFJ) — The Food and Drug Administration granted traditional approval to Eisai and Biogen’s Leqembi (lecanemab-irmb) 100 mg/mL intravenous injection on July 6. It is the first Alzheimer’s drug to clear this regulatory hurdle and aims to slow the disease’s progression.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in FDA’s Center for Drug Evaluation and Research.
