22 July 2022 - Positive opinion based on HELIOS-A Phase 3 study. ...
24 June 2022 - Adverum Biotechnologies today announced that the EMA has granted ADVM-022 Priority Medicines (PRIME) designation for the treatment ...
24 June 2022 - EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) ...
20 May 2022 - First ever gene therapy directly administered into the brain. ...
29 March 2022 - Marketing authorisation application for etranacogene dezaparvovec will be reviewed under accelerated assessment and has the potential to ...
25 March 2022 - EMA has recommended a conditional marketing authorisation in the European Union for Carvykti (ciltacabtagene autoleucel) for the ...
15 December 2021 - CSL Behring today announced that the CHMP, the chief scientific body of the EMA accepted its ...
2 August 2021 - Mustang Bio today announced that the EMA has granted Priority Medicines designation to MB-107, its lentiviral ...
15 July 2021 - Potential first gene therapy in Europe for treatment of haemophilia A. ...
28 June 2021 - Valoctocogene roxaparvovec MAA granted request for accelerated assessment. ...
24 May 2021 - MAA resubmission on track for June 2021. ...
21 May 2021 - The EMA has recommended granting a marketing authorisation in the European Union for the gene therapy ...
19 November 2020 - Oxlumo is the first therapeutic approved for the treatment of primary hyperoxaluria type 1, and the ...
3 November 2020 - GenSight Biologics today reported that the Lumevoq marketing authorisation application passed the validation checks required for submissions ...
16 October 2020 - Ten new medicines recommended for approval. ...