27 April 2022 - Designation Creates Potential to Bring Important New Therapy to Patients Earlier. ...
26 April 2022 - Editas Medicine today announced that the U.S. FDA granted rare paediatric disease designation to EDIT-301, an investigational, ...
26 April 2022 - OVAL Phase 3 top-line progression-free survival primary outcome data for ofra-vec expected in 2H 2022; with ...
25 April 2022 - Autolus Therapeutics today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation to its ...
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies. ...
4 April 2022 - PRGN-3006 UltraCAR-T previously received orphan drug designation in patients with acute myeloid leukaemia by the US FDA. ...
1 April 2022 - Today, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma) for adult patients with ...
22 March 2022 - The BLA has been accepted for quality review and StemCyte anticipates licensure in 2023 ...
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
1 March 2022 - Fast Track Designation granted to improve activities of daily living and muscle strength in patients with ...
28 February 2022 - Approval is primarily based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022. ...
9 February 2022 - Gamida Cell today announced that it has initiated the biologics license application rolling submission process with the ...
31 January 2022 - Updated toxicity management strategy can improve certain adverse events without compromising the activity of Yescarta. ...
18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...