FDA Extends Expiration Date of Immunoglobulin Product Cutaquig
The new expiration date for cutaquig is valid for 42 existing lots that were manufactured and distributed in 2019 and 2020.
The new expiration date for cutaquig is valid for 42 existing lots that were manufactured and distributed in 2019 and 2020.
ACE-1334 is a TGF-beta superfamily-based ligand trap designed to bind and inhibit TGF-beta 1 and 3 ligands.
Avacopan is an orally-administered, small molecule designed to selectively block the complement 5a receptor on destructive inflammatory cells such as blood neutrophils.
ChemoCentryx, Inc has submitted a NDA to the Food and Drug Administration (FDA) for acavopan in the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Janssen has decided to discontinue the phase 3 LOTUS study evaluating ustekinumab (Stelara®) for the treatment of systemic lupus erythematosus.
TLY012, a PEGylated recombinant human TRAIL (TNF-related apoptosis-inducing ligand) protein, binds upregulated death receptor 5 (DR5) on myofibroblasts (MFBs) and selectively blocks activation of MFBs in fibrotic regions.
The FDA has granted Fast Track designation to telitacicept (RC18; RemeGen) for the treatment of systemic lupus erythematosus.
New regulatory pathway for biologic drugs allows for approval of biosimilars, interchangeable versions.
Rate of composite response showing reduced disease activity higher with anifrolumab versus placebo
GlaxoSmithKline announced positive results from the phase 3 BLISS-LN trial of belimumab for the treatment of active lupus nephritis in adult patients.