Novo Nordisk, Sanofi Insulin Combo Products Clear US Regulatory Hurdles
US FDA approves Xultophy and Soliqua, both fixed-ratio combinations of a basal insulin and a GLP-1 agonist, on the same day even though Sanofi redeemed a priority review voucher that earned Soliqua an earlier user fee goal date.
You may also be interested in...
Just as the tulip craze eventually subsided, it appears the pharma industry's infatuation with priority review vouchers also may be waning, as Sarepta sells its voucher for only $125m.
Keeping Track: Approvals For Xultophy, Soliqua And Darzalex; NDAs From Intarcia And GSK; Complete Response For Green Cross
The latest drug development news and highlights from our FDA Performance Tracker
Original new drugs and biologics recently approved by US FDA.