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BioWorld - Wednesday, December 11, 2024
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» Applied Therapeutics pushes NDA filing in galactosemia further back
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Applied Therapeutics pushes NDA filing in galactosemia further back
Jan. 4, 2022
By
Lee Landenberger
No Comments
After discussions with the FDA, Applied Therapeutics Inc. said it will again delay an NDA filing for its galactosemia treatment, AT-007, until it has more time to discuss the filing with the agency.
BioWorld
Regulatory
Endocrine/metabolic
FDA
NDA