RE:RE:RE:FDA seeks Accelerated Approval reform in Spending BillDecember 23, 2022 - Merck’s receives FDA full aproval under an accelerated approval program for anti-PD-1 antibody blockbuster Keytruda in a less-frequent dosing regimen.
[Such a simple reason for full approval under an accelerated approval program suggests that ONCY's opportunity for accelarated approvals in both breast cancer and pancreatic cancer is much mor probable than once thought ]
Merck’s anti-PD-1 antibody blockbuster Keytruda had a less-frequent dosing regimen previously cleared under an accelerated approval converted into full approvals on Dec. 16.
https://endpts.com/fda-quietly-turns-three-keytruda-accelerated-approvals-into-full-approvals/