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 Approves Novel Therapy for Gastroesophageal Reflux
November 2nd 2023Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It will be available in December and has a list price of $650 for a 30-count bottle.
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FDA Assigns Goal Date for Mavorixafor for Rare Immunodeficiency Disease
October 31st 2023If approved, mavorixafor would be the first therapy for WHIM syndrome, an ultra-rare disease that can cause recurrent lung infections, papillomavirus-related warts, and an increased risk of developing certain types of cancer. The PDUFA date is April 30, 2024.
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