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Casgevy FDA Approval History - Drugs. com Casgevy was approved for use in the treatment of sickle cell disease on December 8, 2023 and became the first medicine available in the United States to treat a genetic disease using the CRISPR gene-editing technique
Vertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™… The use of CASGEVY for the treatment of TDT in the U S remains investigational Vertex has submitted a BLA to the U S FDA for the potential use of CASGEVY for patients 12 years and older with TDT and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 30, 2024
Vertex Announces US FDA Approval of CASGEVY - Business Wire “On the heels of the historic FDA approval of CASGEVY for sickle cell disease, it is exciting to now secure approval for TDT well ahead of the PDUFA date,” said Reshma Kewalramani, M D ,
FDA approval of Casgevy and Lyfgenia: a dual breakthrough in gene . . . On 8 December 2023, the US Food and Drug Administration (FDA) granted approval to two cell-based gene therapies, Casgevy (Exagamglogene autotemcel) and Lyfgenia (Lovotibeglogene autotemcel), for the treatment of sickle cell disease (SCD) in patients aged 12 years and older
RoslinCT to manufacture first-ever US FDA approved CRISPR-based gene . . . CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR Cas9 genome-edited cell therapy, was approved by the U S FDA on 8 December 2023 for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises (VOCs)
CASGEVY | FDA CASGEVY indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs)
FDA approves Casgevy, 1st CRISPR therapy for sickle cell disease Casgevy is under standard review in the U S for transfusion-dependent beta thalassemia, a related disorder, and a decision is expected in March Similar applications are being considered in the European Union