bluebird Inc. BLUE announced that the European Medicines Agency (“EMA”) has accepted the company’s marketing authorization application (“MAA”) for its investigational elivaldogene autotemcel (eli-cel, ...
The U.S. FDA said it is investigating the risk of hematologic malignancies associated with Bluebird Bio Inc.’s Skysona (elivaldogene autotemcel), approved in 2022 as a one-time gene therapy for ...
CALD is a rare neurodegenerative disease that can lead to progressive, irreversible loss of neurologic function, and death One-time treatment with SKYSONA has been shown to have a durable effect in ...
bluebird bio to present new data from clinical studies of elivaldogene autotemcel (eli-cel, Lenti-D™) gene therapy at the 46th EBMT Annual Meeting.
Shares of Bluebird Bio Inc. soared 71.8% in premarket trading on Monday, days after a Food and Drug Administration advisory committee voted in favor of two of the company's experimental gene therapies ...
Suggested Remit: To evaluate the benefits and costs of Lenti-D within its marketing authorisation for treating cerebral adrenoleukodystrophy (CALD) for national commissioning by NHS England. Following ...
bluebird Inc. BLUE announced that the European Medicines Agency (“EMA”) has accepted the company’s marketing authorization application (“MAA”) for its investigational elivaldogene autotemcel (eli-cel, ...
Bluebird Bio Inc.’s elivaldogene autotemcel (eli-cel) gained U.S. approval late Sept. 16 for use in early active cerebral adrenoleukodystrophy (CALD), making it the firm’s second gene therapy to clear ...
Lenti-D hematopoietic stem cell gene therapy stabilizes neurologic function in boys with cerebral adrenoleukodystrophy (ALD-102 and ALD-104) Presenting Author: Dr. Jörn-Sven Kühl, Department of ...
bluebird Inc. BLUE announced that the European Medicines Agency (“EMA”) has accepted the company’s marketing authorization application (“MAA”) for its investigational elivaldogene autotemcel (eli-cel, ...
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