Mar 28, 11:45 PM

FDA Extends Review of Applied Therapeutics' Drug for Galactosemia by Three Months Due to Supplemental Analyses

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.

#Applied Therapeutics #FDA #NDA

Written with ChatGPT (GPT-3).

Sources

Reuters@Reuters
2 years ago
US FDA extends review of Applied Therapeutics' genetic disease drug https://t.co/JErrU3WEZs https://t.co/U7Ur42Fs0W
Reuters Health@Reuters_Health
2 years ago
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
PiQ@PiQSuite
2 years ago
⚠️ 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…

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FDA Extends Review of Applied Therapeutics' Drug for Galactosemia by Three Months Due to Supplemental Analyses

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