Latest Breaking News On - Pediatric rare disease - Page 1 : comparemela.com

Applied Therapeutics Reports First Quarter 2024 Financial Results

Applied Therapeutics Reports First Quarter 2024 Financial Results
marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.

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

FDA Presses Delay Button For Applied Therapeutics First Potential Marketed Drug For Rare Disease - Applied Therapeutics (NASDAQ:APLT)

FDA extends the review period for Applied Therapeutics' NDA for govorestat, targeting Classic Galactosemia treatment. The new action date is set for November 28, 2024. Applied Therapeutics anticipates a decision from EMA in Q4 2024.

Committee for medicinal products human useTherapeutics incApplied therapeutics incDrug applicationClassic galactosemiaPrescription drug user fee actApplied therapeuticsMajor amendmentPriority reviewPediatric rare diseasePriority review voucherApplied therapeuticMarketing authorization applicationMedicinal productsHuman use

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
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

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
tmcnet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from tmcnet.com Daily Mail and Mail on Sunday newspapers.

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