February Biotech PDUFA Pulse:
📡 What’s on the FDA Radar
Feb 8 |
$RGNX – RGX-121 (MPS II / Hunter syndrome), Priority Review
Feb 20 |
$MRK – Keytruda® (platinum-resistant recurrent ovarian cancer), Priority Review (label expansion)
Feb 21 |
$VNDA – Bysanti™ (bipolar I disorder / schizophrenia)
Feb 25 |
$ETON – ET-600 (central diabetes insipidus)
Feb 28 |
$ASND – TransCon® CNP (achondroplasia), Priority Review
Feb 28 |
$BMRN – PALYNZIQ® (PKU, adolescents), Priority Review (label expansion)
See the attached graphic for the full February PDUFA calendar.