FDA to review uniQure’s BLA for Huntington’s gene therapy
The submission has been granted Priority Review, setting a target action date of 1 May 2027 under the Prescription Drug User Fee Act (PDUFA). The regulator also indicated
Evommune has secured exclusive rights outside Greater China to develop, manufacture and commercialise EVO570, an autoimmune therapy, from Hinova Pharmaceuticals in a licence deal worth up to around $1.1bn.