GSK: FDA Sets Advisory Committee Meeting To Review NDA For Daprodustat - Quick Facts

GSK plc (GSK,GSK.L) said the FDA will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for daprodustat for the potential treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis. The date for the advisory committee meeting is 26 October 2022.

In June 2022, Duvroq or daprodustat tablets were approved by Japan's Ministry of Health, Labour and Welfare for patients with renal anaemia. In March 2022, the European Medicines Agency validated the marketing authorisation application for daprodustat, which is currently under regulatory review.

For More Such Health News, visit rttnews.com.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Salt Lake City, Utah-based Rocky Mountain Pies, LLC is recalling Red Button Vintage Creamery French Silk Pie citing possible presence of undeclared almonds, a known allergen, the U.S. Food and Drug Administration said. The recall involves 31.88 oz French Silk Pie with the lot code beginning with 2 266. Only UPC code 0 41172 81290 9 is involved in the recall. The U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS has issued a public health alert against Paradise Locker Meats' certain fully cooked summer sausage products. There are concerns that the products may be contaminated with extraneous materials, specifically plastic. A recall was not requested as the products are no longer available for purchase. Hormel Foods Corp. (HRL) said, in the fourth quarter, the company delivered earnings per share comparable with record results last year, which included an additional week of sales. Pretax earnings were $357 million, up 1% from a year ago. Organic net sales were up 2%, excluding the impact of an additional...
Follow RTT