Shots:
The US FDA has received an NDA of lirafugratinib for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement
NDA was backed by the P-I/II (ReFocus) trial, which showed 46.5% ORR, 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), 12mos. OS of 74.6% (mOS: 22.8mos.), DCR of 96.5%, & mDoR of 11.8mos.,…
Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices
Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

