April 22nd 2024
Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
April 11th 2024
FDA Accepts Jardiance sNDA for CKD Indication
January 23rd 2023A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.
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FDA Accepts Application for NASH Drug
January 19th 2023There are currently no medications approved for the treatment of NASH, which can lead to cirrhosis, eventual liver failure, cancer and death. The FDA has assigned a PDUFA target action of June 22, 2023, for the therapy, obeticholic acid.
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