19 сент. 2022 г. · August 17, 2022 Approval Letter - ZYNTEGLO · August 17, 2022 Summary Basis for Regulatory Action - ZYNTEGLO · Approval History, Letters, Reviews ...

17 авг. 2022 г. · ZYNTEGLO is a first-in-class, one-time ex-vivo LVV gene therapy approved for the treatment of beta-thalassemia in adult and pediatric patients ...

ZYNTEGLO™ is an FDA-approved gene therapy that has the potential to free people with beta-thalassemia from regular transfusions.

17 авг. 2022 г. · The FDA has approved ZYNTEGLO (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause ...

18 авг. 2022 г. · FDA approval history for Zynteglo (betibeglogene autotemcel) used to treat Beta Thalassemia. Supplied by Bluebird Bio, Inc.

17 авг. 2022 г. · The clinical pharmacology review team's recommendation for approval of ZYNTEGLO is based on review of data from the two ongoing Phase 3 studies ...

17 авг. 2022 г. · Wednesday, the FDA approved the company's one-time beta thalassemia treatment Zynteglo, also known as betibeglogene autotemcel (beti-cel) ...

See full prescribing information for. ZYNTEGLO. ZYNTEGLO (betibeglogene autotemcel) suspension for intravenous infusion. Initial U.S. Approval: 2022.

23 авг. 2022 г. · The Food and Drug Administration (FDA) has approved beti-cel (brand name Zynteglo ® ), the first potentially curative gene therapy for people who require ...

17 авг. 2022 г. · The FDA Wednesday approved betibeglogene autotemcel (Zynteglo), the first cell-based gene therapy for the treatment of adult and pediatric ...