Shots:
Based on positive results from P-III (REGENCY) study, the US FDA has accepted sBLA of Gazyva in Lupus Nephritis; FDA's approval decision is expected by Oct’25
The P-III (REGENCY) study demonstrated improved CRR with Gazyva + standard therapy vs standard therapy alone, along with improvements in complement levels & reductions in anti-dsDNA, markers…
Shots:
The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025)
sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…
Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices
Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

