23 May 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
22 May 2023 - Sangamo Therapeutics today announced that the US FDA has granted fast track designation to isaralgagene civaparvovec, or ...
19 May 2023 - Today, the US FDA approved Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy, for the treatment ...
15 May 2023 - SiSaf announces that SIS-101-ADO, its siRNA therapeutic, has been granted orphan drug designation and rare paediatric disease ...
3 May 2023 - Gene therapies hold promise for treating a wide range of diseases. Innovative companies such as bluebird bio ...
25 April 2023 - FDA granted accelerated approval of Qalsody based on a reduction of neurofilament, a marker of neurodegeneration. ...
24 April 2023 - BLA submission based on data from the largest and most mature clinical development program for any ...
20 April 2023 - GenSight Biologics today announces that the Committee for Advanced Therapies (CAT) of the CHMP of the EMA ...
11 April 2023 - RGX-202 is a potential one-time AAV therapeutic for the treatment of Duchenne and includes an optimised transgene ...
3 April 2023 - EU and UK filings completed in 2022; submissions validated by EMA and MHRA and the review ...
20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...
21 February 2023 - PDUFA date set for 8 October 2023. ...
20 February 2023 - Hemgenix underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead ...