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US FDA extends review of Applied Therapeutics' genetic disease drug https://t.co/JErrU3WEZs https://t.co/U7Ur42Fs0W
The U.S. Food and Drug Administration has extended its review of Applied Therapeutics' experimental drug to treat galactosemia, a rare genetic metabolic disease, the company said on Thursday. https://t.co/cUKC33VvO8 https://t.co/cUKC33VvO8
⚠️ US FDA EXTENDS REVIEW OF APPLIED THERAPEUTICS' GENETIC DISEASE DRUG Full Story → https://t.co/h9BFQywWvm The U.S. Food and Drug Administration has extended its review of Applied Therapeutics' experimental drug to treat galactosemia, a rare genetic metabolic disease, the…
The U.S. Food and Drug Administration has extended the review period for Applied Therapeutics' genetic disease drug, which is aimed at treating galactosemia, a rare genetic metabolic disease. The FDA required additional time to assess supplemental analyses provided by the company, leading to a three-month extension. The additional information submitted by Applied Therapeutics was deemed a Major Amendment to the New Drug Application (NDA). Investors are closely monitoring the situation, with the review now extended by three months.
