|
- CASGEVY | FDA
CASGEVY indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs)
- Vertex Announces US FDA Approval of CASGEVY™ (exagamglogene autotemcel . . .
“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 , Chief Executive Officer and President of Vertex
- 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
- Search Orphan Drug Designations and Approvals - Food and Drug . . .
*Exclusivity Protected Indications are shown for approvals from 01 01 2013 to the present *Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or
- 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)
- CRISPR Therapeutics Announces U. S. Food and Drug
“We are pleased with the approval of CASGEVY in TDT well ahead of the PDUFA date,” said Samarth Kulkarni, Ph D , Chairman and Chief Executive Officer of CRISPR Therapeutics
- FDA Approves First Gene Therapies to Treat Patients with Sickle Cell . . .
The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older
- Vertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™…
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
|
|
|