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 ...

Conditional approval. This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine ...

ZYNTEGLO™ is an FDA-approved gene therapy that has the potential to free people with beta-thalassemia from regular transfusions. How ZYNTEGLO Works · Treatment Journey · Qualified Treatment Center · FAQs

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 ...

17 авг. 2022 г. · The approval clears the drug for kids and adults with beta thalassemia who require regular red blood cell transfusions, the FDA said in a ...

The recent European Union marketing authorization of Zynteglo (lentiglobin) illustrates how well planned and executed interactions among a medicines developer, ...

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

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 clinical pharmacology review team's recommendation for approval of ZYNTEGLO is based on review of data from the two ongoing Phase 3 studies ...