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Applied Therapeutics Reports First Quarter 2024 Financial Results

Applied Therapeutics Reports First Quarter 2024 Financial Results
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Shoshana shendelmanAdvanz pharmaMaeve conneightonCommittee for medicinal products human useDrug administrationJournal of the american college cardiologyAmerican college of cardiologyTherapeutics incNeurologyi divisionAmerican college of cardiology annual scientific sessionNeurology divisionEuropean medicines agencyExchange commissionClassic galactosemiaPriority reviewAccelerated approval

Applied Therapeutics Says FDA Extends Review Period Of NDA For Govorestat

Applied Therapeutics Says FDA Extends Review Period Of NDA For Govorestat
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Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

NEW YORK, March 28, 2024 Applied Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications.

Advanz pharmaMaeve conneightonShoshana shendelmanExchange commissionCommittee for medicinal products human useEuropean medicines agencyDrug administrationHealth indexTherapeutics incNew drug applicationClassic galactosemiaPrescription drug user fee actApplied therapeuticsMajor amendmentPriority reviewPediatric rare disease

Applied Therapeutics Inc (APLT) Provides FDA Update on PDUFA Date for Govorestat

Applied Therapeutics Inc (APLT) Provides FDA Update on PDUFA Date for Govorestat
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Shoshana shendelmanCommittee for medicinal products human useDrug administrationTherapeutics incApplied therapeuticsNew drug applicationClassic galactosemiaPrescription drug user fee actMajor amendmentPriority reviewPediatric rare diseasePriority review voucherAldose reductase inhibitorGalactosemia kidsApplied therapeuticMarketing authorization application

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
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Advanz pharmaShoshana shendelmanMaeve conneightonDrug administrationHealth indexCommittee for medicinal products human useEuropean medicines agencyTherapeutics incExchange commissionAction dateNew drug applicationClassic galactosemiaPrescription drug user fee actApplied therapeuticsMajor amendmentPriority review