Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review ...

First-ever FDA approval for gene therapy directly administered to the brain - - Priority review voucher granted - - Broad label including children and adults - - ...

Along with the Biologics License Application approval, a Rare Disease Priority Review Voucher was granted. The company plans to monetize the voucher ... This indication is approved under accelerated ...

Both vehicles are available for sale and in full compliance with U.S. Federal Motor Vehicle Safety Standards, EPA and CARB certifications. The Mullen THREE was recently qualified for a $15,000 ...