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European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy

European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy
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European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy

European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy
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Applied Therapeutics Reports Second Quarter 2023 Financial Results

Regulatory progress for govorestat for the treatment of Classic Galactosemia, with potential NDA submission based on discussions with the FDA as well as EMA Marketing Authorization Application.
-Today at 07:04 am- MarketScreener ....

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Applied Therapeutics Provides Regulatory Update on Galactosemia Program

Pre-NDA Meeting to be held with FDA this summer to discuss potential NDA submission for govorestat for treatment of Classic Galactosemia EMA Marketing Authorization Application for govorestat for. ....

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Applied Therapeutics (APLT) Provides Regulatory Update on Galactosemia Program

Applied Therapeutics (APLT) Provides Regulatory Update on Galactosemia Program
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United States , Advanz Pharma , Shoshana Shendelman , Maeve Conneighton , European Medicines Agency , Therapeutics Inc , Drug Administration , Exchange Commission , Applied Therapeutics , United States Food , Pre New Drug Application , Authorization Application , Pediatric Investigational Plan , Aldose Reductase , About Applied , Aldose Reductase Inhibitor , Diabetic Cardiomyopathy , Private Securities Litigation Reform Act ,