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FDA to Review Vertex Pharmaceutical's Application for CRISPR-based Gene Therapy Exa-cel | Goodwin

The Cellular, Tissue, and Gene Therapies Advisory Committee of the FDA is meeting tomorrow, Tuesday, October 31, 2023, to review a Biologics License Application by Vertex. ....

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CRISPR Therapeutics Provides Business Update and Reports Second Quarter 2023 Financial Results

-FDA accepted Biologics License Applications (BLAs) for exagamglogene autotemcel (exa-cel) for severe Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT); Priority Review for SCD and Standard Review for TDT- -PDUFA target action date of December 8, 2023, for SCD and March 30, 2024, for TDT- -Enrollment and dosing ongoing for CTX110®, targeting CD19+ B-cell malignancies, and CTX130™, targeting CD70 for the treatment of T cell lymphomas- -Enrollment ongoing and dosing initia ....

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CRISPR Therapeutics Provides Business Update and Reports Second Quarter 2023 Financial Results

CRISPR Therapeutics Provides Business Update and Reports Second Quarter 2023 Financial Results
itbusinessnet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from itbusinessnet.com Daily Mail and Mail on Sunday newspapers.

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Vertex Pharmaceuticals Incorporated: FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

First CRISPR gene-editing filings to be accepted for review by FDA - FDA grants Priority Review for severe sickle cell disease (SCD) and Standard Review for transfusion-dependent beta thalassemia (TDT) ....

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FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
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