10 июл. 2024 г. · December 8, 2023 Approval Letter - LYFGENIA · December 8, 2023 Summary Basis for Regulatory Action - LYFGENIA · Approval History, Letters, Reviews ...

19 дек. 2023 г. · Lyfgenia FDA Approval History ; FDA Approved: Yes (First approved December 8, 2023) ; Brand name: Lyfgenia ; Generic name: lovotibeglogene ...

8 дек. 2023 г. · The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years ...

8 дек. 2023 г. · LYFGENIA was granted Priority Review in June 2023 . The Company did not receive a Rare Pediatric Disease Priority Review Voucher as part of the ...

7 мая 2024 г. · Lovo-cel was approved as Lyfgenia in December 2023. The first patient with sickle cell disease (SCD) is set to receive bluebird bio's ...

Is LYFGENIA FDA-approved in the US? Yes, LYFGENIA was approved by the FDA in December 2023.

13 дек. 2023 г. · Both therapies will be available in early 2024. “Casgevy's approval by the FDA is momentous: it is the first CRISPR-based gene-editing therapy ...

11 дек. 2023 г. · The FDA has approved Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia gene therapies for the red blood cell disorder.

8 дек. 2023 г. · The FDA has approved bluebird bio's lovotibeglogene autotemcel (lovo-cel), marketed as Lyfgenia, as a treatment for sickle cell disease (SCD) in patients aged ...