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Wilson Bryan, former FDA gene therapy leader, joins consulting firm

Published: July 19, 2023

BioPharma

Source: biopharmadive.com

Related Topics:

Wilson BryanBilly DunnMarion GruberJohn JenkinsPhil KrauseCelia WittenKaren MidthunDrug AdministrationUniversity Of Texas Southwestern Medical SchoolOffice Of TissuesOffice Of New DrugsOffice Of Therapeutic ProductsGreenleaf HealthAdvanced TherapiesTherapeutic ProductsBiologics EvaluationTexas Southwestern MedicalNew Drugs

First Duchenne gene therapy approved by FDA for young children

Published: June 22, 2023

BioPharma

Source: biopharmadive.com

Related Topics:

United StatesSusan FinazzoPeter MarksCelia WittenJennifer HandtDoug IngramJerry MendellLisa LeeJohn BrandsemaTim RevellDrug Administration OnDrug AdministrationSarepta TherapeuticsNationwide ChildrenVirginia TechParent Project Muscular Dystrophy

FDA delays decision on Duchenne gene therapy, considers narrower approval

Published: May 24, 2023

BioPharma

Source: biopharmadive.com

Related Topics:

Jerry MendellBrian AbrahamsCelia WittenRaymond RoosUniversity Of Chicago Medical CenterDrug AdministrationSarepta TherapeuticsChicago Medical CenterNationwide Children

FDA panel narrowly backs approval of Sarepta's Duchenne gene therapy

Published: May 13, 2023

BioPharma

Source: biopharmadive.com

Related Topics:

United StatesAnthony AmatoLisa LeeMelanie HennickEmmanuel Adu GyamfiPeter MarksCaleb AlexanderSteven PavlakisSusan FinazzoCelia WittenDrug AdministrationHealth Sciences UniversitySarepta TherapeuticsBiopharma DiveStat NewsSciences UniversityGene Therapy

Preterm Birth Drug Withdrawn After 12 Years

Published: March 8, 2023

The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.

Source: nytimes.com

Related Topics:

Celia WittenMichael CaromeAnjali KaimalUniversity Of South FloridaCovis Pharma GroupDrug AdministrationSouth FloridaPublic CitizenRecalls And BansPremature BabyPharmaceuticals Prescription DrugsCovis Pharma