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Arcturus Therapeutics Announces Positive Development for Cystic Fibrosis Program

Arcturus to present new Phase 1b interim data for ARCT-032 at European Cystic Fibrosis Conference on June 7, 2024 First four CF patients demonstrated an average improvement of 4% FEV1 after two.

United kingdomUnited statesSan diegoJoseph payneJuergen froehlichDrug administrationMrna technologyArcturus therapeutics holdings incEuropean medicines agencyArcturus therapeutics holdingsEuropean cystic fibrosis conferenceForced expiratory volumeChief medical officerOrphan medicinal product designationOrphan drug designationPrivate securities litigation reform act

Arcturus Therapeutics Holdings Inc Announces Positive Development for Cystic Fibrosis Program

Arcturus Therapeutics Holdings Inc. announced ARCT-032 will be presenting Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational.

European medicines agencyDrug administrationArcturus therapeutics holdings incArcturus therapeutics holdingsEuropean cystic fibrosis conferenceOrphan medicinal product designationOrphan drug designation

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 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

Atamyo Therapeutics Obtains Regulatory Authorization in Europe to Initiate a Clinical Trial for ATA-200, its Gene Therapy to Treat Limb-Girdle Muscular Dystrophy Type 2C/R5

Atamyo Therapeutics Obtains Regulatory Authorization in Europe to Initiate a Clinical Trial for ATA-200, its Gene Therapy to Treat Limb-Girdle Muscular Dystrophy Type 2C/R5
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Sophie olivierDennis riedlCharles craigIsabelle richardItalian medicines agencyOpus biotech communicationsUniversity of milanProgressive muscular dystrophies laboratory at genethonFrench medicines agencyEuropean medicines agencyNational centerScientific researchClinical trial applicationChief medical officerGiacomo comiFull professor