来自MSN2 个月
APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
It also significantly reduced plasma galactitol levels in adults and children with galactosemia. Additional studies provided strong efficacy and safety data across 185 classic galactosemia ...
来自MSN11 个月
FDA extends review period for Applied Therapeutics’ govorestat NDA
the Phase I/II ACTION-Galactosemia study in adults; as well as preclinical findings. If approved, govorestat would become the first medication indicated for the treatment of galactosemia and aid ...