People with hereditary angioedema (HAE), a rare genetic disorder, may experience episodes of debilitating, unpredictable, and potentially life-threatening swelling in the abdomen, larynx (voice box), face, and extremities. But there is a new, first-of-its-kind drug to prevent these attacks: The U.S. Food and Drug Administration (FDA) has approved Andembry (garadacimab), a once-monthly medicine injected under […]
Grocery recalls are becoming increasingly more common. According to compliance company Traceone, the total number of food recalls issued by the Food and Drug Administration and the Department of Agriculture grew 15% between 2020 and 2024. There are various reasons why food may be recalled, ranging from accidental contamination of ingredients to sanitation violations at […]
A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its final rule to regulate laboratory-developed tests as medical devices, effectively eliminating it. The rule, issued last year, would have phased out its general enforcement discretion approach for most lab-developed tests over four years. The […]
The U.S. Food and Drug Administration (FDA) has issued a warning that some people develop severe itching after halting long-term use of the common antihistamines cetirizine (Zyrtec) and levocetirizine (Xyzal). The FDA said in a statement that it will update safety information on the label of these allergy medicines, which are available in both prescription […]
ANI | Updated: Nov 13, 2024 16:11 IST PRNewswireNew York [US], November 13: Fourth Frontier, a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the Frontier X Plus from the U.S. FDA. The Frontier X Plus is an innovative single-lead, continuous ECG monitor that is worn around the […]
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