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Certa Therapeutics FT011 Granted US FDA Fast Track for the Treatment of Systemic Sclerosis

MELBOURNE, Australia, Feb. 19, 2024 (GLOBE NEWSWIRE) Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), having previously granted Orphan Drug Designation.[1] The Fast Track Designation was granted based on r

Darren kellySue charlesKirrily davisEuropean medicines agencyAustralian therapeutic goods agencyDrug administrationFast track designationOrphan drugLacerta therapeuticsNew drug applicationAccessed januaryNon invasive surrogatesSystemic sclerosisAustralian therapeutic goodsOrphan drug designationFast track

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma
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University collegeNew south walesUnited statesCity ofUnited kingdomSan diegoInternationalsue charlesDarren kellyFrederickgl huetwellAustraliakirrily davisScleroderma programDrug administrationEuropean medicines agencyAustralian therapeutic goods agencyAmerican college of rheumatologyProfessor chris denton md university college london

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma
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University collegeNew south walesSan diegoUnited statesUnited kingdomCity ofKirrily davisDarren kellyFrederickgl huetwellSue charlesEuropean medicines agencyDrug administrationAmerican college of rheumatologyScleroderma programAustralian therapeutic goods agencyCentre for rheumatology

Certa Therapeutics FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis

Certa Therapeutics FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis
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San diegoUnited statesIhre chancenDarren kellyIndiens wirtschaftAmerican college of rheumatology annual meetingEuropean medicines agencyDrug administration orphan designationAustralian therapeutic goods agencyDrug administrationOrphan drug designationDrug designationProfessor darren kellyLacerta therapeuticsAmerican collegeRheumatology annual meeting

Certa Therapeutics FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis

Certa Therapeutics FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis
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San diegoUnited statesDarren kellyDrug administrationEuropean medicines agencyAustralian therapeutic goods agencyDrug administration orphan designationAmerican college of rheumatology annual meetingOrphan drug designationDrug designationProfessor darren kellyLacerta therapeuticsAmerican collegeRheumatology annual meetingDrug administration orphanAccessed october