12 October 2021 - GenSight Biologics today announced that the U.S. FDA has granted fast track designation to GS030, which combines ...
21 September 2021 - Biologics license application submission based on data from Phase 1/2 and Phase 3 Northstar studies, which ...
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
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. ...
8 July 2021 - Lysogene today announced that the U.S. FDA has granted fast track designation to its LYS-GM101 program, which ...
28 June 2021 - Valoctocogene roxaparvovec MAA granted request for accelerated assessment. ...
28 June 2021 - LGMD2I/R9 is a rare form of muscular dystrophy with no approved therapies. ...
22 June 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in PD-1-refractory ...
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 ...
18 May 2021 - The US FDA is not amenable to changing study outcome measures or sample sizes for gene therapy ...
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...
22 April 2021 - Rapid publication following approval. ...
20 April 2021 - LX1001 is the first investigational gene therapy being evaluated to address the underlying genetics of Alzheimer’s disease. ...