Novo's Diabetes Combo May Find Home With General Practitioners
This article was originally published in The Pink Sheet Daily
Despite FDA skepticism about fixed dosing, advisory committee says there are patients and providers who will benefit.
You may also be interested in...
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.
FDA request for more information on pen injector forces three-month review extension, offsetting advantage from priority review voucher redemption.
CBER director does not want to hold back potentially beneficial products, but also warned that patients will have difficult treatment decisions to make since an immune response might prevent a patient from receiving another gene therapy using the same vector ever again.